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Table of Contents Introduction What is Regulatory Affairs? What Regulatory Affairs Involves Why Regulatory Affairs Is Critical The African Context: Challenges & Opportunities How MC Pharma Adds Value Regulatory-Affairs Careers and Job Roles Conclusion Works Cited Contact MC Pharma for Your Regulatory Affairs Needs Introduction Regulatory Affairs (RA) is the multidisciplinary profession that ensures medicines, vaccines, medical devices and other health products are developed, assessed, authorised and maintained in line with statutory requirements. For companies operating in, or entering, South Africa and the broader African market, a robust RA strategy is the difference between timely patient access and costly delays. What is Regulatory Affairs? RA is the discipline that ensures every stage of product development from pre-clinical studies to post-marketing surveillance complies with prevailing laws, guidelines and ethical standards. Professionals in this field liaise with regulators, prepare technical dossiers and monitor changes in legislation to maintain ongoing compliance. Globally accepted frameworks such as ICH guidelines, Good Laboratory/Clinical/Manufacturing Practice (GLP/GCP/GMP) and the Common Technical Document (CTD) underpin most submissions. History Regulatory affairs emerged in the 1960s after a series of drug-safety crises underscored the need for stringent oversight. Today it bridges science, law and business, translating complex statutes into actionable pathways that protect patients while enabling innovation . What Regulatory Affairs Involves Pillar Typical activities Regulatory intelligence Tracking legal changes (e.g., SAHPRA’s 2025–26 Performance Plan) ( sahpra.org.za ) Strategy Selecting full, abridged or reliance review; planning data packages (ICH CTD) ( au.int ) Dossier preparation Compiling Modules 1–5; formatting to eCTD for SAHPRA portal ( ectd.sahpra.org.za ) Authority liaison Responding to SAHPRA, FDA, EMA questions; negotiating timelines ( sahpra.org.za ) Lifecycle management Variations, renewals, pharmacovigilance, labelling updates ( sahpra.org.za ) Key Frameworks SAHPRA  – Medicines & Related Substances Act 101/1965; risk-based and reliance review models cut median approval from 26 months to <18 months. Collaborative Frameworks include: Recognised Regulatory Authorities (RRAs) including EU CP, EU DCP, EMA national/MRP, US FDA, Health Canada, MHRA (UK), PMDA/MHLW (Japan), SwissMedic, TGA (Australia), WHO-listed authorities, and others listed in the guideline. ZaZiBoNa is a work‑sharing framework in which participating national regulators retain sovereign decision‑making, but rely on a common technical evaluation and harmonised standards to reduce duplication, shorten timelines and build regulatory capacity across the region WHO collaborative registration procedures: WHO prequalification collaborative registration for PQ products and WHO SRA‑approved collaborative mechanisms EU and Swiss collaborative mechanisms: EMA mutual recognition and national procedures, and SwissMedic’s MAGHP (Marketing Authorisation for Global Health Products) procedure African Medicines Agency (AMA) : use of AMA structures and procedures as an additional reliance/collaborative route once operational. EU‑M4all and other global‑health programmes: reliance on EU‑M4all decisions and similar mechanisms to support registration of global‑health products. ICH & WHO  – Provide global CTD, GxP and pharmacovigilance standards adopted by African regulators. Why Regulatory Affairs Is Critical Patient safety & public trust  — Only products proven safe, effective and high-quality reach the market. Commercial timelines  — Each month of delay can cost a novel drug US$1–2 million in lost sales. Risk mitigation  — Non-compliance triggers recalls, fines and reputational damage. Market access  — Reliance pathways let SAHPRA accept FDA/EMA assessments, trimming dossier review by 30-40 %. Continental harmonisation  — AMA will enable mutual recognition, reducing duplicate filings. The African Context: Challenges & Opportunities Challenge Impact Emerging solution Fragmented national rules Individual Dossier submission per country to address regional requirements.  AMA work-sharing & SADC/ZAZib reliance routes ( au.int ) Historic SAHPRA backlog Launches >2 years behind US/EU Risk-based & verified reviews; eCTD portal ( sahpra.org.za ,   ectd.sahpra.org.za ) Need for local MAH Foreign Principals to comply with national Licence requirements, Contract MAH model under Section 22C (MC Pharma) Post-market vigilance Resource-heavy Outsourced PV & QMS aligned to WHO UMC ( sahpra.org.za ) How MC Pharma Adds Value Licensing & representation MC Pharma is licensed under Section 22C(1)(b) to act as Applicant and Marketing-Authorisation Holder, removing the need for a foreign subsidiary to establish a legal presence in the area. eCTD authoring & publishing In-house suite converts global CTDs into SAHPRA-ready eCTD sequences, performs XML validation and manages lifecycle updates Strategic regulatory planning The team prepares reliance-route justifications, gap analyses and dossiers tailored for abridged or verified review, shortening approvals. Section 21 permission for unregistered medicines (SA) MC Pharma (acting as a Section 21 Co-Applicant) can facilitate the application process, regulatory compliance and logistics for unregistered-medicine imports in terms of Section 21, enabling medicine access for the Healthcare Provider. Quality & supply chain MC Pharma can link Principals with GDP-compliant distribution via a vetted network of four distributors and 35 wholesalers. Regulatory-Affairs Careers and Job Roles Regulatory-affairs (RA) careers span from entry-level officers who compile dossiers to senior executives who direct global compliance strategy. Demand is strong in South Africa, the UK/EU and worldwide as regulators tighten oversight and companies accelerate new-product launches. Typical progression is: RA Assistant RA Associate RA Officer / RA Pharmacist RA Specialist Senior RA Specialist/RA Project Manager RA Manager / Head of RA RA Director / Responsible Pharmacist Core Skills Include: Scientific literacy Dossier authoring Negotiation Project management Emerging niches : RegTech implementation AI-enabled data analysis CMC variation strategy and post-market vigilance are creating hybrid roles that blend IT with traditional RA expertise. MC Pharma’s Section 22C licence, eCTD infrastructure and continent-wide client base give professionals exposure to multiple markets. Typical Job Titles & Progression Level Representative titles Primary focus Entry (0-2 yrs) Regulatory Affairs Officer / Associate Data gathering, eCTD formatting, basic variations Early career (2-5 yrs) RA Specialist / Analyst Dossier authoring, literature review, responding to minor SAHPRA RFIs Mid-career (5-8 yrs) Senior Specialist / Project Manager Leads submissions, cross-functional liaison, mentors juniors Management (8-12 yrs) RA Manager / CMC Manager Portfolio strategy, resource planning, regulator negotiation Senior leadership (>12 yrs) Director / Senior Director Global policy, risk governance, authority engagement at senior level Executive Head of Regulatory Affairs / Responsible Pharmacist / Qualified Person (QP) Corporate compliance vision, M&A diligence, board reporting Core Responsibilities by Seniority Officers & Associates  – assemble CTD modules, track regulatory intelligence, create label text Specialists  – write scientific justifications, prepare variation and renewal packages, co-ordinate with QA and PV teams Managers  – craft submission strategies (full vs. reliance), budget regulatory projects, manage authority meetings Directors/RP/QP  – set global policies, oversee inspection readiness, integrate regulatory input into corporate strategy Competencies & Qualifications Category Key requirements Education BSc/PharmD/MBChB minimum; MSc Regulatory Science or RAC credential highly valued Technical skills eCTD publishing, GxP knowledge, CMC change control, PV systems Soft skills Analytical thinking, clear writing, stakeholder negotiation, attention to detail Market Outlook Industry surveys project a compound annual growth rate of 5–7 % in global RA head-count through 2030, driven by expanding regulatory frameworks and harmonisation initiatives such as the African Medicines Agency (RAPS, 2024) . Digitalisation, reliance pathways and AI-assisted dossier preparation are expected to accelerate both demand and role diversification with associated increasing cost of compliance. Emerging & Specialised Roles Niche role Drivers RegTech Implementation Lead Deploys AI/ML tools for automated vigilance reporting and compliance analytics CMC Variation Strategist Manages post-approval changes across multi-country filings Label & Artwork Compliance Manager Oversees digital artwork management and UDI/2D-barcode mandates AI-Assisted Regulatory Data Scientist Uses LLMs to interrogate clinical and quality data for rapid response dossiers Reliance Pathway Advisor (Africa) Navigates SADC/AMA work-sharing to cut review times by 30–40 % Conclusion Regulatory Affairs is both a public-health safeguard and a strategic business lever. As SAHPRA modernises and collaborative harmonisation gathers pace, companies that embed African-centred RA early - and partner with licensed experts like MC Pharma - will reach patients sooner, stay compliant longer and build sustainable market leadership. Frequently Asked Questions (FAQs) about SAHPRA What is regulatory affairs? A profession that ensures every phase of drug development, approval and post-marketing meets legal, safety and quality requirements set by regulators such as SAHPRA, EMA and FDA. Why does SAHPRA require eCTD? Electronic CTD standardises dossier structure, speeds review and supports full lifecycle tracking through the SAHPRA portal. How long does SAHPRA approval take? Full reviews can exceed 18 months, but abridged or verified reliance routes may conclude within 9-12 months when global data are leveraged. What is Section 21? A legal mechanism allowing controlled import of unregistered medicines for specific patients when no registered alternatives exist. How can MC Pharma accelerate launches? By acting as local MAH, compiling SA-eCTDs, leveraging reliance pathways, managing Section 21 requests and maintaining post-market compliance. Focused, High-Volume GLOBAL FAQs on Regulatory Affairs Question Answer 1. What is regulatory affairs in the life-sciences sector? Regulatory affairs (RA) is the profession that interprets and applies government regulations to ensure that medicines, medical devices, cosmetics and related products are researched, manufactured, distributed and monitored in compliance with safety, quality and efficacy standards ( topra.org ,   abpi.org.uk ). 2. Why is regulatory affairs important to public health and to companies? RA protects patients by preventing unsafe or ineffective products from reaching the market and saves companies time and money by guiding them through compliant development and approval pathways, thereby avoiding costly delays, recalls or legal penalties ( synergbiopharma.com ,   abpi.org.uk ). 3. What does a regulatory affairs specialist do on a day-to-day basis? Typical tasks include tracking regulatory updates, compiling and publishing Common Technical Document (CTD/eCTD) dossiers, submitting variations, liaising with authorities (e.g., SAHPRA, EMA), reviewing labels, ensuring marketing compliance and coordinating with quality, clinical and pharmacovigilance teams ( graduate.northeastern.edu ,   careerinpharma.com ). 4. What qualifications and skills are needed to enter regulatory affairs? Most entry roles require at least a Bachelor of Science, Pharmacy or Engineering degree; postgraduate certificates (e.g., MSc Regulatory Science) or the RAPS RAC credential add advantage. Essential skills include scientific literacy, attention to detail, clear technical writing, project management and negotiation ( indeed.com ,   mhaonline.com ,   raps.org ). 5. How does regulatory affairs differ from quality assurance (QA)? RA ensures products meet external legal and regulatory requirements and obtains market authorisations, whereas QA focuses on internal systems that keep manufacturing and testing processes consistently within predefined quality standards. Both collaborate, but RA is outward-facing to regulators while QA is inward-facing to production operations ( graduate.northeastern.edu ,   indeed.com ). Works Cited African Union. (2025). High-level working breakfast on operationalizing the African Medicines Agency (AMA).   https://au.int   ( au.int ) BioBoston Consulting. (2024). The crucial role of regulatory affairs in the product lifecycle.  Retrieved July 7 2025. ( globalforum.diaglobal.org ) Food & Drug Administration. (2024). Drug recalls, withdrawals & safety alerts.   https://www.fda.gov   ( sahpra.org.za ) Ndlovu, S., et al. (2023). Implementation of a risk-based assessment by SAHPRA.   Therapeutic Innovation & Regulatory Science,  57(4), 589-599.   https://pubmed.ncbi.nlm.nih.gov   ( sahpra.org.za ) SAHPRA. (2025). Annual performance plan 2025–2026.   https://www.sahpra.org.za   ( sahpra.org.za ) SAHPRA. (2024). eCTD portal user guide.   https://ectd.sahpra.org.za   ( ectd.sahpra.org.za ) SAHPRA. (2025). Guideline 2.24 – Submission of ZA-CTD/eCTD applications.   https://www.sahpra.org.za   ( au.int ) Topra. (2024). What is regulatory affairs?   https://www.topra.org   ( freyrsolutions.com ) World Health Organization. (2024). Good pharmacovigilance practices.   https://www.who.int   ( sahpra.org.za ) MC Pharma. (2024). Company profile (Internal document). Contact MC Pharma for Your Regulatory Affairs Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction What is International Dossier Evaluation? Global Harmonisation: CTD & eCTD Evaluation Pathways & Timelines Why Dossier Evaluation Matters MC Pharma’s Role in International Dossier Evaluation Practical Submission Tips Frequently Asked Questions (FAQs) Works Cited Need help turning your draft dossier into an approval-ready eCTD? Introduction International Dossier Evaluation is the systematic, evidence-based appraisal of a Common Technical Document (CTD/ eCTD) by national regulatory authorities (NRAs) to confirm the safety, efficacy and quality of a health product before approval. Harmonised guidelines from the ICH, EMA, FDA, WHO and SAHPRA increasingly promote work-sharing, reliance and electronic formats, allowing well-prepared dossiers to move faster across borders. This article explains the principles, benefits and challenges of international dossier review and shows how MC Pharma’s regulatory team helps sponsors navigate each stage from technical gap analysis to post-approval life-cycle management. What is International Dossier Evaluation? An international dossier is the full CTD or eCTD package submitted to an NRA for marketing authorisation, comprising five modules that cover administrative data, quality, non-clinical and clinical evidence (ICH, 2003) (ich.org) . Dossier evaluation is the scientific and regulatory assessment of this file to decide whether public-health standards are met (Kolabtree, 2021) (kolabtree.com). Global Harmonisation: CTD & eCTD CTD Frameworks ICH M4 created a common format recognised in the EU, US, Japan and many low- and middle-income countries, reducing duplicative compilation (ICH, 2003) (ich.org) . eCTD Transition Electronic publishing adds structured XML backbones, hyper-links and validation rules that speed up review cycles and life-cycle tracking (WHO, 2023) (cdn.who.int) . Evaluation Pathways & Timelines Region Standard timeline* Reliance / accelerated options EMA (EU) 210 days active review under the Centralised Procedure (EMA, 2025) ( ema.europa.eu ) Accelerated assessment ≤ 150-200 workingdays for public-health priority medicines (EMA, 2025) ( ema.europa.eu ) FDA (US) 10-month standard cycle; Complete-Response Letter issued if deficiencies remain (FDA, 2024) ( fda.gov ) Priority Review = 6 months; Real-Time Oncology Review, etc. WHO n/a  (global norm-setting body) Collaborative Registration Procedure (CRP) shares WHO PQ assessment with NRAs, cutting approval to 60-90 days (WHO, 2024) ( extranet.who.int ) SAHPRA (South Africa) 200-350 days for full review Abridged/verified review within 90-180 days using recognised reference authority reports (SAHPRA, 2024) ( sahpra.org.za ) *Clock-stops for sponsor questions excluded. Why Dossier Evaluation Matters Patient safety  - ensures robust benefit–risk evidence before supply (WHO, 2023) ( cdn.who.int ). Regulatory efficiency  - harmonised templates allow NRAs to focus on critical data, trimming redundant review (EMA, 2025) ( ema.europa.eu ). Market access & cost savings  - effective reliance can shorten African approvals by >50 % (Azatyan, 2023) ( cdn.who.int ) ; continental frameworks under the African Medicines Agency will deepen this cooperation (AUDA-NEPAD, 2025) ( nepad.org ) . MC Pharma’s Role in International Dossier Evaluation Gap analysis & CTD authoring  – senior pharmacists benchmark your draft against ICH M4Q/M4S/M4E and SAHPRA reliance criteria. eCTD publishing & validation  – in-house EXTedo® experts structure, hyperlink and run technical validation to eliminate errors before upload. Reference-authority bridging  – we compile comparative tables showing alignment with EMA/FDA assessment reports to qualify for abridged review in South Africa or other SADC markets. Life-cycle management  – MC Pharma tracks sequence updates, variations and renewals so the dossier stays compliant across jurisdictions. Training & strategic advice  – workshops on Good Reliance Practices (GRP) and dossier readiness for African NRAs. For service details see our   Regulatory Intelligence  and   eCTD Management  pages. Practical Submission Tips Align Module 1 early - regional forms cause most clock-stops; pre-validate with each target NRA. Leverage public assessment reports - copy EMA’s European Public Assessment Report (EPAR) structure to demonstrate consistency. Use a master data backbone - regulatory information management (RIM) software reduces version-control errors. Plan for reliance - collect certified unredacted assessment reports from reference authorities at time of first approval; SAHPRA requires them in Module 1.10 (SAHPRA, 2024) ( sahpra.org.za ). Maintain an audit trail - regulators increasingly request e-signatures and change logs. Frequently Asked Questions (FAQs) What is an international dossier? A harmonised CTD or eCTD package containing quality, non-clinical and clinical data that supports marketing authorisation in multiple regions. How does reliance shorten dossier review? By allowing an NRA to use another trusted agency’s full assessment report, reducing duplicate scientific work and trimming timelines by months. Is the CTD compulsory in South Africa? Yes. SAHPRA mandates CTD or eCTD format for all new chemical entities, generics and, biological medicines. What documents are critical for an abridged review? Certified unredacted assessment reports, GMP certificates, risk-management plans and final approved labelling from the reference authority. How can MC Pharma help with multi-country submissions? We prepare region-specific Module 1s, publish compliant eCTDs and coordinate simultaneous filings while managing all NRA queries. Works Cited European Medicines Agency. (2025). The evaluation of medicines: step-by-step . ( ema.europa.eu ) European Medicines Agency. (2025). Accelerated assessment . ( ema.europa.eu ) Food and Drug Administration. (2024). FDA’s drug review process . ( fda.gov ) ICH. (2003). M4: Common Technical Document (CTD) guideline . ( ich.org ) Kolabtree. (2021). What is a regulatory dossier and what does it contain?   ( kolabtree.com ) South African Health Products Regulatory Authority. (2024). Reliance guideline (SAHPGL-BAU-01 v4) . ( sahpra.org.za ) World Health Organization. (2023). Good Reliance Practices technical briefing . ( cdn.who.int ) World Health Organization. (2024). Collaborative procedure for accelerated registration of IVDs . ( extranet.who.int ) Azatyan, S. (2023). WHO efforts to promote reliance . ( cdn.who.int ) AUDA-NEPAD. (2025). Continental regulatory reliance framework for the African Medicines Agency . ( nepad.org ) Need help turning your draft dossier into an approval-ready eCTD? Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction About Pharmalane UK (and why their audits carry weight) What Pharmalane UK audits cover and which standards they use Outcome (and why “audit closed” matters) What this means for MC Pharma’s clients Why this strengthens future collaborations How to request the audit report About MC Pharma Connect With Us Frequently Asked Questions How MC Pharma Provides Services & Consulting Introduction On 11 March 2025 , MC Pharma completed an audit by Pharmalane UK Ltd.  covering Good Distribution Practice (GDP)  and pharmacovigilance (PV) . A formal Audit Compliance Report  was submitted in April 2025 ; corrective actions were accepted and the audit was officially closed .   For clients, this means independent confirmation that our distribution controls and safety systems meet internationally recognised benchmarks (EU GDP and EMA GVP) while aligning with SAHPRA  requirements in South Africa. About Pharmalane UK (and why their audits carry weight) Pharmalane UK  is a global GxP auditing provider (GMP, GDP, GPvP/GVP, GCP) with a ready audit-report library and the capacity to conduct new audits on request through a worldwide network of experienced auditors. Their model shortens supplier qualification by enabling stakeholders to procure an existing report or commission a fresh audit quickly. Reports are not public ; they are provided on request  to bona fide stakeholders (typically via their library or direct enquiry). Why this helps you:  for manufacturers, MAHs and distributors looking at MC Pharma as a partner in South Africa, a recent, independent GDP/PV audit  by a recognised specialist can materially reduce qualification timelines and internal audit burden. What Pharmalane UK audited and against which standards The audit evaluated our distribution and safety-monitoring systems against internationally recognised frameworks and local requirements: EU Guidelines on Good Distribution Practice (GDP)  for medicinal products for human use — baseline expectations for quality systems, documentation, temperature control, segregation, deviations and CAPA across the supply chain. EMA Good Pharmacovigilance Practices (GVP) — Module IV (Pharmacovigilance audits)  — risk-based PV audit strategies, grading (critical/major/minor), reporting and follow-up. Relevant ISO standards  — supporting quality-management system effectiveness and continual improvement. Local GDP regulations in South Africa  — including SAHPRA Good Wholesaling/Distribution Practice expectations for wholesalers and distributors. Other applicable international regulatory guidance  — ensuring alignment with globally recognised best practice for distribution and pharmacovigilance. Outcome (and why “audit closed” matters) Audit conducted:  11 March 2025 (remote/desktop). Compliance Response:  Audit Compliance Report submitted in April 2025. Status:  Corrective actions accepted, audit closed. “Closed” indicates that observations were addressed to the auditor’s satisfaction via CAPA - consistent with GDP and GVP audit principles and with SAHPRA’s inspection-response expectations. In practice, it shows our quality system is effective, documented and responsive to risk . What this means for MC Pharma’s clients - Right Now Proven distribution controls (GDP):  Independent review against EU GDP provides assurance over storage, handling, traceability, temperature control, segregation and documentation - all key to product integrity and patient safety. Robust safety governance (PV):  Alignment with GVP  confirms our pharmacovigilance system - case handling, signal oversight, governance and audit readiness - meets recognised best practice for MAH obligations. Reduced due-diligence burden:  A recent third-party GDP/PV audit streamlines supplier questionnaires, reduces duplicate audits and accelerates quality-agreement finalisation. Local readiness, global standards:  Compliance with SAHPRA  Good Wholesaling/Distribution Practice and inspection-response guidance demonstrates local alignment while meeting EU/UK expectations - ideal for regional programmes running on global QMS frameworks. Why this de-risks and strengthens future collaborations Faster supplier qualification:  Pharmalane UK's ready report library and ability to conduct new audits on demand materially shorten timelines for qualification. Lower onboarding friction:  With CAPA accepted and the audit closed, fewer gaps need remediation during tech transfer or market entry. EU/UK-friendly frameworks:  Reliance on EU GDP  and GVP  provides familiar benchmarks for QA, QP/RP/RPi oversight. Execution in South Africa:  Local GDP/GWP alignment supports compliant import, warehousing, distribution and PV operations for the SA market. How to request the audit report The report is not publicly available . Eligible stakeholders may request access via MC Pharma  or procure via Pharmalane UK’s audit-report library  (or request a new audit if needed). We’ll coordinate secure sharing with appropriate NDAs where required. About MC Pharma MC Pharma (Pty) Ltd is a South African regulatory-pharmaceutical consultancy  (licensed under Section 22C ), offering regulatory intelligence, pharmacovigilance/ADR support , imports/exports & distribution , and eCTD publishing & submissions , among other services. Connect With Us Manufacturers / MAHs: Request the Pharmalane UK audit package and book a regulatory roadmap session to align GDP/PV expectations for South Africa and broader African market entry. Distributors / Market entrants: Talk to us about imports, warehousing, distribution, pharmacovigilance and ADR reporting support as a service  tailored to your portfolio, backed by multiple approvals and independent audits Frequently Asked Questions (FAQ) Was this a GMP audit? No. This specific Pharmalane UK assessment focused on Good Distribution Practice (GDP) and Pharmacovigilance (PV), not manufacturing (GMP). GMP requirements and audits are handled separately where applicable. Why reference EU GDP/GVP for a South African company? EU GDP and EMA GVP are widely recognised global benchmarks. Used together with SAHPRA guidance (for example, Good Wholesaling/Distribution Practice and inspection-response expectations), they provide a strong, internationally aligned framework for operating in South Africa while meeting the expectations of global QA, QP and regulatory teams. What does “audit closed” actually mean? “Closed” means findings were addressed through CAPA; the auditor has completed their review, accepted the company’s responses and formally concluded the audit process in line with GDP/GVP and SAHPRA inspection-response principles. In MC Pharma’s case, this sits alongside existing licences and approvals as another piece of external confirmation around systems that are already in routine use. Can our QA team rely on this for supplier qualification? In many organisations, yes. Independent GDP/PV audits are commonly used as part of supplier qualification to reduce duplicated effort and accelerate vetting. Pharmalane UK’s model — combining a ready report library with the option for new audits — is recognised by QA and QP teams globally and can be used alongside MC Pharma’s existing approvals and licences for a fuller picture. Can anyone download the report? No. Audit reports are not public. Access is limited to eligible stakeholders via MC Pharma or Pharmalane UK and is usually handled under appropriate confidentiality arrangements (for example NDAs) as part of supplier qualification or partnership discussions. How MC Pharma Provides Services & Consulting As a licensed Marketing Authorisation Holder (MAH)  under Section 22C of the Medicines and Related Substances Act, MC Pharma offers end-to-end regulatory consulting and compliance support for both medicines and medical devices in South Africa. Our services include: Regulatory Affairs Consulting  – Guiding clients through SAHPRA requirements, classification, and registration strategies. eCTD Dossier Management  – Compilation, publishing, submission, and lifecycle management of regulatory dossiers. Pharmacovigilance  – Monitoring, reporting, and managing adverse events to ensure ongoing safety compliance. Borderline Product Support  – Assisting with classification assessments and preparing submissions for SAHPRA determination. Import & Export Logistics  – Managing compliant movement of medicines and devices across borders, including post-importation quality testing. Quality Management Systems  – Developing, implementing, and auditing QMS to SAHPRA standards. Why Choose MC Pharma? MC Pharma combines over 26 years of regulatory experience  with a deep understanding of the South African pharmaceutical and medical device landscape to deliver compliant, efficient, and market-ready solutions for local and international clients. 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction Understanding SAHPRA: South Africa's Health Products Regulator Core Regulatory Functions of SAHPRA The Impact of SAHPRA on the South African Health Product Landscape Navigating SAHPRA Regulations: Guidance for Industry Professionals Partnering for Compliance: How MC Pharma Can Assist Frequently Asked Questions (FAQs) about SAHPRA Footnotes Works Cited Contact MC Pharma for Your Regulatory Affairs Needs Introduction The South African Health Products Regulatory Authority (SAHPRA) stands as the central pillar regulating the safety, quality, and efficacy (“SQE”) of health products within South Africa. For any organisation involved in the development, manufacturing, importation, distribution, wholesale, or sale of medicines, medical devices, or related health products in the country, a thorough understanding of SAHPRA is fundamental to operational success and compliance. This guide, presented by MC Pharma , aims to provide industry professionals with a comprehensive overview of SAHPRA's structure, its core regulatory functions, its tangible impact on the market, and strategic considerations for navigating its complex landscape.  Leveraging deep expertise in South African pharmaceutical regulations , this article serves as to clarify and give guidance to professionals in their interactions with the Authority. Project-specific information can be requested by contacting us and scheduling a consultation with one of our specialist business development executives. Understanding SAHPRA: South Africa's Health Products Regulator The Mandate and Mission of SAHPRA SAHPRA's existence and operational parameters are primarily defined by the Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended. Its core mandate is unequivocal: to safeguard public health by ensuring that all health products available in South Africa meet stringent standards of safety, efficacy, and quality. This overarching responsibility translates into a mission focused on promoting and protecting the health of the nation through regulation that is effective, efficient, and transparent. SAHPRA aims to promote access to health products through science-based regulatory decisions. A critical aspect of SAHPRA's role is its significantly expanded scope compared to its predecessor, the Medicines Control Council (MCC). The Authority oversees a wide spectrum of health products, including: Human and veterinary medicines Medical devices (encompassing in-vitro diagnostics or IVDs) Complementary medicines (CAMs) Radiation control This broad remit signifies a holistic approach to health product regulation. The inclusion of medical devices and IVDs, under a single, robust regulatory framework mandated to improvement of resources and efficiency was a key driver for SAHPRA's establishment in February 2018. Furthermore, the requirement for continuous post-market surveillance and vigilance across all these product categories underscores the depth of SAHPRA's oversight. This comprehensive scope inherently increases the regulatory surface area that companies must navigate, demanding integrated compliance strategies. Historical Context: From MCC to SAHPRA SAHPRA officially commenced operations on 1 February 2018, replacing the long-standing Medicines Control Council (MCC). This transition represented a fundamental legislative and operational overhaul designed to address systemic weaknesses and modernise South Africa's regulatory framework. Key factors necessitating this change included: Need for Autonomy:  A recognised need for a more autonomous regulatory body, structured as a standalone public entity (Schedule 3A) rather than operating directly within the National Department of Health, to enhance efficiency and decision-making independence. Addressing Backlogs:  The MCC faced persistent challenges, most notably significant backlogs in the evaluation of medicine registration dossiers (inheriting approx. 16,000 applications, some dating back to 1992), which hampered timely access to new therapies. Modernising Device Regulation:  The regulatory framework under the MCC lacked robust provisions for the rapidly evolving field of medical devices. The establishment of SAHPRA aimed directly at rectifying these issues by creating a more agile, better-resourced agency with a mandate explicitly covering the full spectrum of health products and aligning South Africa more closely with international regulatory best practices. Understanding this history illuminates SAHPRA's strategic objectives – efficiency, comprehensiveness, international credibility – and helps anticipate its regulatory posture. Organisational Structure and Key Units SAHPRA is established as a Schedule 3A public entity under the Public Finance Management Act (PFMA) , reporting to the National Minister of Health. This structure grants it operational autonomy while maintaining public accountability. The Authority is governed by a Board appointed by the Minister of Health, which oversees strategic direction and governance. Members of the Board and committees must declare any commercial interests related to the pharmaceutical or healthcare industry. Operationally, SAHPRA is organised into several key units, each responsible for specific regulatory functions. The core divisions typically include: Chief Executive Officer's Office:  Oversees overall administration and strategic implementation. Regulatory Evaluation and Management / Medicines Evaluation and Registration:  Primarily responsible for the scientific evaluation of registration dossiers for medicines (including generics, new chemical entities, biologics) and CAMs. This unit also handles variations to existing registrations and product renewals. Medical Devices, Diagnostics and Digital Health / Radiation Control:  Dedicated to the evaluation and registration of medical devices and IVDs, applying a risk-based classification system. This unit also manages the licensing of relevant establishments dealing with devices and oversees radiation control. Inspectorate and Regulatory Compliance:  Conducts inspections to verify compliance with Good Manufacturing Practice (GMP), Good Wholesaling Practice (GWP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP). It is responsible for issuing licences to manufacturers, importers, exporters, wholesalers, and distributors, and undertakes enforcement actions when necessary. Clinical Evaluation and Management:  Reviews applications for and oversees the conduct of clinical trials in South Africa, ensuring adherence to ethical and scientific standards. Pharmacovigilance:  Monitors the safety of health products once they are on the market, managing the collection and analysis of adverse event reports and implementing risk mitigation strategies. Statutory advisory committees, composed of external experts, often support the evaluation processes within these units. Understanding this structure is vital for effective interaction with the Authority. Key SAHPRA Units and Primary Responsibilities Unit/Division Name Key Responsibilities Regulatory Evaluation & Management Evaluation of registration dossiers (medicines, CAMs); Variations; Renewals. Medical Devices, Diagnostics & Digital Health Evaluation and registration of medical devices and IVDs; Licensing relevant establishments; Radiation Control. Inspectorate & Regulatory Compliance GMP/GWP/GDP inspections; Licensing of manufacturers, wholesalers, distributors; Enforcement actions. Clinical Evaluation and Management Authorisation and oversight of clinical trials. Pharmacovigilance Monitoring product safety post-market; Managing adverse drug reaction reports; Signal detection; Risk management. Core Regulatory Functions of SAHPRA SAHPRA executes several critical functions mandated by legislation, all aimed at ensuring health products available in South Africa are safe, effective, and of suitable quality. These include: Product Registration and Evaluation Licensing of Establishments Clinical Trial Authorisation Pharmacovigilance and Post-Market Surveillance Inspections and Enforcement Product Registration and Evaluation Processes (Medicines, Medical Devices, IVDs) No health product – whether a medicine, medical device, IVD, or complementary medicine – can be legally marketed, distributed, or sold in South Africa without prior authorisation (registration) from SAHPRA. This market authorisation is granted only after a rigorous evaluation process assessing the product's quality, safety, and efficacy. Key aspects of the process involve: Dossier Submission:  Submitting a comprehensive data package (dossier), often in the Common Technical Document (CTD) format for medicines. Evaluation:  The dossier undergoes administrative screening and scientific evaluation by SAHPRA experts. Product-Specific Processes:  SAHPRA manages distinct processes for medicines, and medical devices/IVDs (based on risk classification Classes A-D). Specific Pathways:  Provisions exist for reliance (leveraging assessments from recognised international regulators) and emergency use authorisation (Section 21 permits), though standard registration is the primary route. Timeline Challenges:  Historically, backlogs caused significant delays. While the initial backlog was cleared, ongoing efficiency remains crucial for industry planning. Delays impact market access, commercial strategy, and investment. Licensing of Manufacturers, Wholesalers, and Distributors Beyond product registration, SAHPRA regulates entities in the supply chain through establishment licensing. Who Needs a Licence:  Any company manufacturing, importing, exporting, wholesaling, or distributing health products requires a valid SAHPRA licence for specific activities at a particular site. (Note: Certain Class A medical device establishments are exempt). Compliance Standards:  Licences depend on demonstrating compliance with Good Manufacturing Practice (GMP) for manufacturers and Good Wholesaling Practice (GWP) / Good Distribution Practice (GDP) for distributors/wholesalers. Verification:  Compliance is verified through inspections by SAHPRA's Inspectorate. Importance:  This licensing ensures supply chain integrity and requires ongoing investment in quality management systems and inspection readiness. Clinical Trial Authorisation and Oversight SAHPRA authorises and oversees clinical trials conducted in South Africa. Dual Authorisation:  Before a trial commences, sponsors need authorisation from SAHPRA and  approval from a registered Health Research Ethics Committee (HREC). Application Requirements:  Submission requires detailed documentation (protocol, investigator's brochure, consent forms, ethics approval, safety plans). SAHPRA Evaluation:  Applications are evaluated for scientific soundness, ethical acceptability, and participant safety. Ongoing Oversight:  During the trial, SAHPRA reviews safety reports, amendments, and may conduct site inspections for Good Clinical Practice (GCP) compliance. Significance:  Rigorous oversight ensures data integrity, protects participants, and upholds South Africa's research reputation. Specific guidelines detail requirements. Pharmacovigilance and Post-Market Surveillance SAHPRA's oversight continues post-market authorisation through pharmacovigilance – monitoring product safety throughout its lifecycle.  Core Activities:  This involves collecting, assessing, and preventing adverse effects or other product-related problems. Reporting System:  SAHPRA operates a national system relying on reports of suspected adverse drug reactions (ADRs) and medical device incidents from healthcare professionals, patients, and industry. Signal Detection & Action:  The Authority analyses reports for safety signals and can take regulatory actions (labelling updates, communications, restrictions, recalls/withdrawals). MAH Obligations:  Market Authorisation Holders (MAHs) must report ADRs within specified timelines (e.g., serious ADRs ≤ 15 calendar days), submit Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation Reports (PBRERs), and often appoint a qualified person for pharmacovigilance (QPPV). Resources:  SAHPRA provides specific forms and guidelines for ADR reporting. Inspections and Enforcement Activities SAHPRA conducts inspections of facilities (manufacturers, wholesalers, distributors, clinical trial sites) to ensure compliance. Purpose:  Inspections verify adherence to standards like GMP, GWP/GDP, and GCP. Enforcement Tools:  If non-compliance is found, SAHPRA can issue warning letters, require corrective actions, suspend/revoke licences, order recalls, seize products, or pursue legal action. Importance:  The Inspectorate's activities demand continuous inspection readiness from companies. The Impact of SAHPRA on the South African Health Product Landscape Ensuring Safety, Efficacy, and Quality Standards SAHPRA acts as a crucial gatekeeper, preventing substandard, unsafe, or ineffective health products from reaching the market. Its rigorous evaluation, licensing, inspection, and surveillance activities aim to ensure products meet internationally benchmarked standards, contributing to public health and trust in the healthcare system. Market Access Dynamics and Timelines SAHPRA's processes, especially product registration, significantly influence market access timelines. Historical backlogs, although officially cleared, highlighted the impact of delays on business strategy, investment, and launch decisions. While turnaround times have reportedly improved (e.g., to around 18 months post-backlog project), SAHPRA's efficiency relative to other regulators remains a point of discussion. Effective regulatory navigation can provide a competitive advantage. Alignment with International Regulatory Standards SAHPRA is globally recognised and is a global Regulatory “player”. As of 1 December 2025 – SAHPRA is officially a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). SAHPRA’s participation in PIC/S and ICH gives South African Applicants and Manufacturers very tangible advantages in GMP acceptance, dossier design, and international market access, even though the memberships are formally between authorities rather than with industry directly. GMP, inspections and licences (PIC/S) SAHPRA’s GMP standards and inspectorate are aligned with PIC/S, and the South African Guide to GMP. As a PIC/S authority, SAHPRA participates in work‑sharing and reliance on inspections by other PIC/S members, which reduces the need for duplicate inspections of the same site and supports smoother recognition of foreign GMP for imported products. SAHPRA’s GMP certificates are accepted by the global PIC/S member countries, so a South African site with SAHPRA GMP will find it easier to trade internationally because foreign regulators and procurers have more confidence in the inspection and quality standard. Similarly for registration strategy and dossier expectations , a CTD compiled to mainstream ICH expectations (Q, S, E, M series) is more likely to be accepted without major SA‑specific re‑work. This alignment strengthens SAHPRA’s reliance pathways: applications supported by assessment reports and PI/PIL from recognised regulatory authorities (RRA). Navigating SAHPRA Regulations: Guidance for Industry Professionals Key Guidelines, Legislation, and Fees Legislation:  The primary law is the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and its regulations. Guidelines:  Practical implementation is detailed in numerous guidelines, notices, and SOPs published on the official SAHPRA website ( sahpra.org.za ). Regularly consulting the website is essential for the latest versions. Fees:  SAHPRA operates on a cost-recovery basis with published fee schedules for applications, licences, inspections, etc. Annual retention fees are also payable for registered products and licences. Failure to pay fees can lead to cancellation. Companies must budget for these costs and use current schedules. Common Submission Challenges and Best Practices Common submission challenges include: Incomplete Dossiers Administrative Errors Ignoring Local Regional Requirements Inadequate Responses to Queries GMP Compliance Issues Best practices to mitigate these include: Thorough Preparation:  Understand relevant guidelines and use SAHPRA checklists. Attention to Detail:  Ensure accuracy in forms and technical data alignment. Address SA Specifics:  Proactively identify and meet unique South African requirements. Quality Dossier:  Submit robust, well-organised data (e.g., CTD format). Timely and Complete Responses:  Address SAHPRA queries promptly and comprehensively. Pre-Submission Meetings:  Utilise consultation meetings where available. Local Expertise:  Engage regulatory consultants or local affiliates with SAHPRA knowledge. Utilising SAHPRA's Online Portals and Resources SAHPRA has implemented a digital system and online portals (e.g., eCTD Submissions Portal, Engagement Portal) for submissions and communication.  Familiarity with these systems is crucial. The SAHPRA website (sahpra.org.za) remains the central hub for legislation, guidelines, forms, fees, news, safety alerts, and contacts. Partnering for Compliance: How MC Pharma Can Assist The complexities of SAHPRA's regulatory environment underscore the value of expert support. MC Pharma, licensed under Section 22C of the Medicines Act, offers specialised expertise to navigate this landscape effectively. Supporting Your SAHPRA Submissions and Compliance Strategy MC Pharma provides end-to-end regulatory affairs support tailored to SAHPRA's requirements: Applicant & MAH Services:  We can act as the official Applicant and Marketing Authorisation Holder (MAH) on behalf of principals or product owners, simplifying market entry for companies without a local presence. Regulatory Intelligence & Strategy :  We offer consulting and quality assurance, providing up-to-date insights into SAHPRA regulations and helping develop tailored compliance strategies. Dossier Management (eCTD) :   Our team assists with the full electronic Common Technical Document (eCTD) process, including compilation, publishing, and submission to SAHPRA, life cycle variations and renewal submissions ensuring dossiers meet the required technical specifications. Submission Management:  We manage the submission process through SAHPRA's systems, handle variations and renewals, and liaise with the Authority throughout the product lifecycle. Pharmacovigilance Support:   We provide comprehensive Pharmacovigilance and Adverse Drug Reaction (ADR) support to ensure patient safety and meet SAHPRA's post-market surveillance obligations. Import/Export & Distribution :  We facilitate the import, export, distribution, and wholesale of health products, ensuring adherence to licensing and GWP/GDP requirements. Business Development :   We assist with market entry strategies and navigating the regulatory landscape for new products in South Africa, including NAPPI Code applications, Marketing Code compliance, SEP submissions and Health Technology Assessments (HTA’s). Engaging MC Pharma's expertise helps mitigate risks associated with errors or non-compliance, addresses timeline challenges through optimised submissions, ensures local requirements are met, and ultimately saves time and resources while accelerating market access. Explore how MC Pharma's regulatory affairs services  can support your specific needs. Staying Informed on SAHPRA Updates Keeping abreast of SAHPRA's dynamic regulatory landscape is crucial but demanding. Partnering with MC Pharma ensures clients remain informed about critical developments impacting their products and operations. We actively monitor SAHPRA communications, analyse new guidelines, and provide timely updates and strategic advice to help clients adapt proactively. Accessing MC Pharma's latest regulatory insights  can provide valuable perspectives on the evolving environment. Frequently Asked Questions (FAQs) about SAHPRA What are the main differences between SAHPRA and the old MCC? SAHPRA replaced the Medicines Control Council (MCC) in 2018. Key differences include SAHPRA's structure as an independent public entity (Schedule 3A) for greater autonomy, its expanded mandate covering medical devices, IVDs, and radiation control alongside medicines , and a stronger legislative focus on efficiency, addressing backlogs, and international alignment. How long does product registration typically take with SAHPRA? Timelines vary significantly based on product type, submission pathway, dossier quality, and SAHPRA's workload. While the major inherited backlog was cleared by late 2022, leading to reported improvements (e.g., ~18 months turnaround cited post-project), applicants should consult current SAHPRA guidelines and factor potential processing times into planning. Reliance pathways may offer faster routes. Does SAHPRA regulate medical devices and diagnostics? Yes, regulating medical devices, including in-vitro diagnostics (IVDs), is a core part of SAHPRA's mandate. This involves evaluation and registration based on a risk classification system (Class A-D) and licensing of manufacturers, importers, and distributors (except for certain Class A devices). Can I use my FDA/EMA approval to register my product in South Africa? Approval by agencies like the FDA or EMA does not grant automatic registration in South Africa. However, SAHPRA does utilise reliance pathways, potentially leveraging assessments from recognised regulators to expedite its own review. A formal application addressing all South African requirements must still be submitted to and approved by SAHPRA. Where can I find the latest SAHPRA guidelines and fee schedules? The official SAHPRA website (sahpra.org.za) is the definitive source for the most current guidelines, regulations, application forms, fee schedules, and official communications. It is crucial to refer directly to the website regularly due to frequent updates. Footnotes Adverse Drug Reaction (ADR):  Defined by SAHPRA (based on historical MCC guidelines) as a noxious and unintended response to a medicine in humans or animals, including lack of efficacy, occurring at any dosage, and potentially resulting from overdose, misuse, or abuse. For post-marketing, this applies to doses normally used in humans. A Serious  ADR is one that results in death, is life-threatening, requires or prolongs hospitalisation, results in persistent/significant disability/incapacity, or is a congenital anomaly/birth defect. Works Cited Who we are - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/who-we-are/ Medicines and Related Substances Act (previously Drugs Control Act) 101 of 1965 | South African Government, accessed April 24, 2025, https://www.gov.za/documents/drugs-control-act-7-jul-1965-0000 1 Medicines and Related Substances Control Act 101 of 1965 after amendment by the Medicines and Related Substances Control Amend - FAOLEX Database | Food and Agriculture Organization of the United Nations, accessed April 24, 2025, https://faolex.fao.org/docs/pdf/saf153154.pdf ACT 101 1965.pdf - South African Government, accessed April 24, 2025, https://www.gov.za/sites/default/files/gcis_document/201505/act-101-1965.pdf MEDICINES AND RELATED SUBSTANCES ACT NO. 101 OF 1965 - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2020/01/abdb0bc7MedicinesandRelatedSubstancesAct101of1965asatMay2017.pdf ANNUAL PERFORMANCE PLAN - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2022/03/SAHPRA-Annual-Performance-Plan-2020-2021.pdf annual report 2020|21 | sahpra, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2021/10/SAHPRA-202021-Annual-Report.pdf Backlog - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/backlog/ SAHPRA celebrates the conclusion of the backlog clearance project -, accessed April 24, 2025, https://www.sahpra.org.za/press-releases/sahpra-celebrates-the-conclusion-of-the-backlog-clearance-project/ STRATEGIC PLAN - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2020/07/SAHPRA-Strategic-Plan-2020-22_V4-18320.pdf SAHPRA clears backlog of new drugs registrations, but 'still too slow' - Juta MedicalBrief, accessed April 24, 2025, https://www.medicalbrief.co.za/sahpra-clears-backlog-of-new-drugs-registrations-but-still-too-slow/ Fee Schedule and Explanatory Notes – Renewal of the Certificate of Registration - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2025/02/Communication-to-stakeholders_Renewals-Fee-schedule-and-Explanatory-Notes.docx.pdf Fee Schedule and Explanatory Notes – Renewal of the Certificate of Registration - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/document/fee-schedule-and-explanatory-notes-renewal-of-the-certificate-of-registration/ Guideline for Classification of Medical Devices and IVDs - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/document/guideline-for-classification-of-medical-devices-and-ivds/ Guideline for Classification of Medical Devices and IVDS | SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2024/08/SAHPGL-MD-04_v4-Guideline-for-Classification-of-MD-and-IVDs1.pdf Medical Devices - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/medical-devices/ GOOD MANUFACTURING PRACTICES GUIDELINES - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/good-manufacturing-practices-guidelines/ Clinical Trials - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/clinical-trials/ Safety Information Updates/Pharmacovigilance - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/safety-information-and-updates/ General Information Guideline - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/document/general-information-guideline/ Guidelines - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/guidelines/ SAHPRA - South African Health Products Regulatory Authority, accessed April 24, 2025, https://www.sahpra.org.za/ GWP GUIDELINE FOR THE IMPORTERS AND DISTRIBUTORS OF SCHEDULED SUBSTANCES - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2024/04/SAHPGL-LIC-05_v1-GUIDELINE-ON-IMPORTATION-AND-DISTRIBUTION-OF-SCHEDULED-SUBSTANCES.pdf Guideline for Good Manufacturing Practice - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/document/guideline-for-good-manufacturing-practice/ Clinical Trials Guidelines - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/clinical-trials-guidelines/ FAQs - Clinical Trials - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/faqs-clinical-trials/ reporting adverse drug reactions in south africa - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2020/01/ae9635a42.11_ADR_reporting_May03_v1_2.pdf Post-Marketing-Repor.. - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2020/09/Post-Marketing-Reporting-of-ADRs-to-Human-Medicines-in-SA_Version-7showing-changes_Sept2020.docx GUIDELINE FOR PROFESSIONAL INFORMATION FOR HUMAN MEDICINES (CATEGORIES A AND D) - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-CEM-02_v6-Guideline-for-Professional-Information-for-Human-Medicines-Categories-A-D.pdf Payment of Retention Fees for the Year Ending 31 December 2025 | SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2025/03/Payment-of-Retention-Fees-for-the-Year-Ending-31-December-2025.pdf Newly Gazetted Regulation Regarding Fees Payable in Terms of the Medicines and Related Substances Act - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/document/newly-gazetted-regulation-regarding-fees-payable-in-terms-of-the-medicines-and-related-substances-act/ MC Pharma Group - PharmaBoardroom, accessed April 24, 2025, https://pharmaboardroom.com/directory/mc-pharma-group/page/2/ Your Pharmaceutical Regulatory Partner | MC Pharma, accessed April 24, 2025, https://www.mcpharma.co.za/contact-us OR Tambo pharma backlog causes chronic medicine delays - Freight News, accessed April 24, 2025, https://www.freightnews.co.za/article/or-tambo-pharma-backlog-causes-chronic-medicine-delays Contact Us, Location Addresses & Phone Numbers - McKesson, accessed April 24, 2025, https://www.mckesson.com/contact-us/ Pharma Regulatory Consultants LLC, accessed April 24, 2025, https://www.pharmaregllc.com/ Recall, Adverse Event, and Post-Marketing Vigilance Reporting of Medical Devices and IVDs - SAHPRA, accessed April 24, 2025, https://www.sahpra.org.za/wp-content/uploads/2025/01/8.04_Recalls_Vigilance_Medical_Devices_IVDs_Nov19_v3.pdf MC Pharma: Pharmaceutical Regulatory Services in South Africa, accessed April 24, 2025, https://www.mcpharma.co.za/ Contact MC Pharma for Your Regulatory Affairs Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction About Funky Socks Day (and why it matters) Who Benefits From Funky Socks Day? Outcome (and why participation today matters) What this means for MC Pharma’s community involvement How you can get involved (right now) Funky Socks Day Images Frequently Asked Questions (FAQ) Contact MC Pharma for Your Pharmaceutical Regulatory Needs Introduction Today, 12 September 2025, South Africans and Namibians are wearing their funkiest socks in support of vulnerable children. Funky Socks Day , led by PNA, raises funds through R10/N$10 sticker sales, with proceeds benefiting Breadline Africa, CHOC Childhood Cancer Foundation, Rally to Read, and Matla a Bana. These organisations focus on early childhood development, literacy, and care for children in crisis . For schools, companies, and communities, the initiative is a fun, accessible way to contribute to meaningful causes — and a reminder that small acts of solidarity can make a big impact. About Funky Socks Day (and why it matters) Funky Socks Day is celebrated annually on 12 September. Participants wear bright, mismatched, or patterned socks while contributing R10 for a sticker. The campaign combines fun with purpose — showing children that communities care, while raising funds for vital development and protection programmes. By joining in, schools, businesses, and individuals help raise millions of rand each year for charities that create safer learning spaces, fight illiteracy, and support children facing illness or abuse. Who Benefits From Funky Socks Day? Breadline Africa  – builds and refurbishes safe early childhood development centres, replacing unsafe structures with proper classrooms, kitchens, and toilets. CHOC Childhood Cancer Foundation SA   – supports children with cancer and blood disorders, ensuring continuity of education and emotional care during treatment. Rally to Read  – delivers books, trains teachers, and empowers parents to strengthen literacy in under-resourced schools. Matla a Bana   – provides comfort packs and support for children who have suffered abuse, working alongside police and hospitals. Outcome (and why participation today matters) Funds raised  directly impact early learning, literacy, and child safety programmes. Awareness created  by wearing funky socks reminds everyone that vulnerable children need ongoing support. Community unity : schools, offices, and households across South Africa and Namibia join hands in a shared cause. What this means for MC Pharma’s community involvement As a trusted   licensed regulatory-pharmaceutical consultancy , MC Pharma recognises that health, safety, and education are interlinked . Supporting initiatives like Funky Socks Day aligns with our values of respect, equality, and responsibility to society. Today, our team proudly wears funky socks to: Raise awareness about literacy and ECD. Encourage clients, colleagues, and friends to participate. Showcase our commitment to community-based initiatives beyond the regulatory environment. Our broader mission is to uphold integrity and patient safety — from   pharmacovigilance and ADR reporting support  to   distribution & wholesale under SAHPRA   and   end-to-end eCTD management . Taking part in Funky Socks Day is a natural extension of our role in promoting well-being across society. How you can get involved (right now) Buy your sticker  at PNA (R10 in South Africa / N$10 in Namibia). Wear your funky socks  today and show your support. Post on social media  using #FunkySocksDay2025 and #RockYourFunkySocks. Donate or volunteer  directly through the beneficiary organisations. 👉 Learn more and get involved via PNA Funky Socks Day 👉 Contact MC Pharma   if you’d like to partner with us on future community initiatives. Funky Socks Day Images Frequently Asked Questions (FAQ) What is Funky Socks Day?   It’s a fundraising initiative held annually on 12 September in South Africa and Namibia to support vulnerable children, literacy, and early childhood development. How much does it cost to participate?   Participation is R10 in South Africa or N$10 in Namibia for a sticker, plus wearing your funkiest socks. Where does the money go? Funds are donated to Breadline Africa, CHOC Childhood Cancer Foundation, Rally to Read, and Matla a Bana. Can schools and companies take part? Yes — schools and businesses across both countries actively participate by selling stickers, wearing socks, and raising awareness. What if I don’t have funky socks? You can still support by buying a sticker, making a donation, or spreading awareness online. Contact MC Pharma for Your Pharmaceutical Regulatory Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Introduction In the highly regulated pharmaceutical industry, ensuring safety, efficacy, and quality of medicines is paramount.  This process does not end at product registration but continues throughout the entire lifecycle of a medicine.  The ongoing vigilance is known as Pharmacovigilance. For companies entering or operating in the South African pharmaceutical market, pharmacovigilance is not just a regulatory obligation — it is an ethical responsibility. At MC Pharma, we serve as your trusted partner in navigating these critical safety requirements, offering end-to-end pharmacovigilance solutions aligned with the latest SAHPRA  (South African Health Products Regulatory Authority) regulations. What is Pharmacovigilance? Pharmacovigilance refers to the scientific and systematic process of detecting, assessing, understanding, and preventing adverse drug reactions (ADRs) or other drug-related issues . Globally recognised by the World Health Organization (WHO) , pharmacovigilance aims to ensure that medicinal products remain safe and effective when used by patients under real-world conditions. In South Africa, pharmacovigilance is governed by SAHPRA , which mandates that all licensed pharmaceutical companies and marketing authorisation holders (MAHs/Applicants) implement pharmacovigilance systems as per local regulatory requirements. Source: SAHPRA Pharmacovigilance Guidelines Why is Pharmacovigilance Important? Protects Patient Safety:  Early detection and management of adverse drug reactions reduce the risk of serious health consequences. Regulatory Compliance:  Compliance with SAHPRA is mandatory for maintaining market authorisation. Public Confidence:  Builds trust with healthcare professionals, patients, and regulators. Risk-Benefit Monitoring:  Continuous monitoring, trending and reporting ensures that the benefit-risk profile of a product remains positive throughout its lifecycle. Pharmacovigilance Requirements in South Africa (SAHPRA Standards) South Africa’s regulatory framework is aligned with ICH E2E  global standards and WHO guidelines, while incorporating country-specific nuances: ADR Reporting Timelines Serious ADRs: report within 15 calendar days . Non-serious ADRs: report within 90 calendar days . Risk Management Plans (RMPs) Mandatory for all new marketing authorisation applications. Must be updated periodically and submitted to SAHPRA. Pharmacovigilance Officer (QPPV Equivalent) Companies must appoint a trained, dedicated pharmacovigilance officer responsible for all safety-related submissions and communications with SAHPRA. Continuous Safety Monitoring Regular collection, assessment, and reporting of adverse events. Compliance Inspections SAHPRA regularly conducts inspections to ensure MAHs comply with pharmacovigilance requirements. The Pharmacovigilance Process: Step-by-Step Signal Detection Identification of new or known adverse drug reactions through spontaneous reports, literature, and post-marketing studies. Adverse Event Collection Collection and documentation of ADRs via healthcare professionals, patients, or internally. Assessment & Analysis Evaluation of the seriousness, expectedness, and causal relationship. Regulatory Reporting Submission to SAHPRA in line with required timelines via the official ADR Reporting Portal or email: adr@sahpra.org.za Risk Management Implementation of RMPs, including minimisation measures and ongoing monitoring. Training & Awareness Ensuring all internal and external stakeholders are trained on pharmacovigilance obligations. MC Pharma's Pharmacovigilance Services At MC Pharma , we offer an integrated pharmacovigilance solution that covers the entire regulatory and safety spectrum for companies entering or operating in the Southern African region. Our Services Include: Acting as your official local Marketing Authorisation Holder (MAH) and QPPV . Establishing and maintaining SAHPRA-compliant pharmacovigilance systems . Risk Management Plan  development, implementation, and maintenance. Management of local ADR collection , assessment, and reporting. Monitoring of regulatory safety  data  Internal audits  and regulatory compliance inspections . Pharmacovigilance training for your teams . SAHPRA liaison  for all safety-related matters. Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma is your strategic partner for patient safety , regulatory excellence , and market success . Best Practices for Implementing Pharmacovigilance If you are an international or local pharmaceutical company planning to enter the Southern African market, these are essential steps: Establish a local pharmacovigilance system that meets SAHPRA requirements. Appoint a dedicated qualified pharmacovigilance officer or outsource to MC Pharma’s QPPV. Develop and maintain a robust Risk Management Plan (RMP). Implement internal SOPs governing ADR collection and reporting. Regularly update safety data and submit Periodic Safety Update Reports (PSURs). Train internal teams on pharmacovigilance obligations. Recommended Resources: SAHPRA Official Website WHO Pharmacovigilance ICH E2E Pharmacovigilance Guideline MC Pharma Services Overview Frequently Asked Questions (FAQ) What is Pharmacovigilance?   Pharmacovigilance is the practice of monitoring, detecting, and preventing adverse drug reactions (ADRs) to ensure medicines are safe and effective during real-world use. Who regulates Pharmacovigilance in South Africa?   The South African Health Products Regulatory Authority (SAHPRA)  governs all pharmacovigilance activities in the country. What counts as an ADR?   An Adverse Drug Reaction (ADR)  is any unwanted or harmful reaction resulting from the use of a medicinal product under normal conditions. What happens if ADRs are not reported?   Failure to report ADRs within the SAHPRA-specified timeframes may result in regulatory sanctions, suspension of marketing authorisation, or product recalls. How does MC Pharma assist with Pharmacovigilance?   MC Pharma offers full pharmacovigilance services including ADR reporting, Risk Management Plan development, pharmacovigilance system setup, and acting as your official MAH. Contact MC Pharma for Your Pharmacovigilance Needs 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

What is SAPHEX? The South African Pharmaceutical Exhibition (SAPHEX)  is Africa’s premier forum for pharmaceutical manufacturing, packaging, supply-chain and regulatory stakeholders. Scale & purpose —  The 2025 edition hosted 100+ exhibitors  and 2 000+  professionals at Johannesburg’s Sandton Convention Centre , delivering two days of expert talks, live demonstrations and networking under the banner “Uniting Healthcare.” Knowledge streams —  Delegates moved between a GMP/GDP symposium and hands-on Strategnos workshops that covered SAHPRA inspections, pharmacovigilance, validation and logistics. Co-located power —  SAPHEX shares the floor with   The Pharmacy Show (TPS ), GP Expo  and The Hospital Show , giving visitors a one-stop venue where pharmacists, GPs and hospital leaders explore end-to-end healthcare innovation. MC Pharma – 26 Years of Regulatory Depth and Market Reach Founded in 1999, MC Pharma (Pty) Ltd. holds licences under Section 22C of the Medicines & Related Substances Act 101 of 1965 and serves as Marketing Authorisation Holder (MAH) and SAHPRA liaison for local and global clients. Comprehensive, Modular Services Regulatory intelligence & eCTD publishing  – 1 500+ dossiers compiled and maintained. Quality assurance (QA/QMS)  – GMP-aligned systems, GLP/SANAS support and audit readiness. Sales & marketing  – national key-account coverage across South Africa, Namibia, Lesotho, Botswana and Eswatini. Import & export logistics  – customs clearance, bonded storage and cold-chain management through various distributors and wholesalers Global Perspective, Local Precision MC Pharma supports innovators from the UK, Australia, Brazil, China, India, Israel, Germany, France and the USA while contributing expertise to industry bodies such as MCA, SMASA and SAPRAA. The company’s mission upholds integrity, transparency and empowerment, safeguarding patient health by delivering compliant products to African markets. Mnandi Pharma – Medical-Device Partner & Sister Company Mnandi Pharma , a strategic partner to MC Pharma, focuses exclusively on medical devices and in-vitro diagnostics (Classes A–D). Core Competencies SAHPRA establishment licensing  – guiding manufacturers through applicant, importer and distributor approvals. Import / export administration  – bonded storage, customs clearance and temperature-controlled consignments. Distribution oversight  – managing national wholesaler networks for rapid, compliant rollout. Product classification advice  – helping clients determine the correct risk class and document route. Synergy With MC Pharma By combining Mnandi’s device expertise with MC Pharma’s medicines portfolio, clients enjoy a single integrated partner for multi-category product launches—a strength showcased at their joint Silver Sponsor  stand during SAPHEX 2025. Why SAPHEX Matters South Africa’s pharmaceutical market is forecast to exceed US $6 billion by 2026. SAPHEX delivers direct insight from SAHPRA, unveils first-to-market technologies and fosters partnerships essential for success in a rapidly expanding African sector. Register Now for SAPHEX 2026 SAPHEX returns 25 – 26 March 2026  at Sandton Convention Centre, with 25% more floor space already reserved. Secure your delegate or exhibitor pass today   and stay ahead in Africa’s evolving pharmaceutical landscape. Download Event Prospectus SAPHEX Event Images Frequently Asked Questions (FAQ) What does SAPHEX stand for?   South African Pharmaceutical Exhibition—Africa’s flagship platform for pharma manufacturing, packaging and regulation. How long has MC Pharma operated?   26 years (est. 1999). How is Mnandi Pharma related to MC Pharma? Mnandi Pharma is MC Pharma’s sister company and strategic partner focusing on medical-device licensing, import/export and distribution. When and where is SAPHEX 2026? 25 – 26 March 2026 at Sandton Convention Centre, Johannesburg. How can I work with MC Pharma? Visit mcpharma.co.za/contact  or email pharmacist@mcpharma.co.za  for a complimentary regulatory-roadmap session. Contact MC Pharma for Your Pharmacovigilance Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction What Is the eCTD? Why the eCTD Matters Inside an eCTD Dossier SAHPRA’s Current Rules Six Common Pitfalls & Quick Fixes How MC Pharma Makes It Easy Eight Key Take-aways FAQs References Introduction The Electronic Common Technical Document ( eCTD ) is now the universal format for medicine dossiers. South Africa’s regulator, South African Health Product Regulatory Authority , requires all medicine & health product applications, variations and renewals to be uploaded via its eCTD Portal from 2024 onwards ( ectd.sahpra.org.za ). Mastering eCTD management is therefore essential for local approval—and for leveraging the same dossier in other markets. What Is the eCTD? The eCTD is the digital, hyper-linked version of the CTD defined by ICH M8 . It places every quality, non-clinical, clinical and administrative file in a fixed folder tree and links them through an XML “table of contents” backbone ( ICH ,  ICH Admin ). Regulators open that XML and click bookmarks to reach any page instantly—no paper, no couriers. Why the eCTD Matters Benefit Advantage for applicants Evidence Global acceptance One core dossier serves FDA, EMA, SAHPRA and 20 + other agencies EFPIA white paper ( EFPIA ) Faster reviews Searchable PDFs; no shipping delays SAHPRA Q&A & Portal ( ectd.sahpra.org.za ,  SAHPRA ) Built-in validation Software flags naming, link or PDF errors before submission SAHPRA Module 1 spec v3.1 ( ectd.sahpra.org.za ) Lifecycle clarity Updates arrive as numbered “sequences” regulators can track ICH eCTD spec 3.2.2 ( ICH ) Inside an eCTD Dossier Module Core content 1 – Regional (ZA) eCTD-1 form, GMP/CPP certificates, PI/PIL, cover letter, etc. ( ectd.sahpra.org.za ) 2 – Summaries Quality Overall Summary, clinical & non-clinical overviews and regional information 3 – Quality Full CMC data: composition, specs, stability and regional specific information 4 – Non-clinical Animal pharmacology & toxicology reports 5 – Clinical Human-trial reports, statistics & post-marketing safety data Each update is a sequence  that adds, replaces or deletes files while preserving dossier integrity ( ICH Admin ). SAHPRA’s Current Rules Mandatory Portal  – All orthodox and biological medicines must be filed via SAHPRA’s eCTD Portal; paper and NeeS are no longer accepted ( ectd.sahpra.org.za ) . ZA Module 1 v3.1 (Mar 2024)  – Follow SA-specific folder names, envelope XML and validation checklist ( ectd.sahpra.org.za ). Pre-submission validation  – Submissions failing automated checks are rejected before scientific review. Baseline conversions  – Legacy paper/NeeS dossiers need a one-off sequence 0000 before any further variation. Six Common Pitfalls & Quick Fixes Pitfall Rapid fix Source 1. Un-bookmarked or scanned PDFs Use searchable templates; add bookmarks before compile ClinReg article ( Clinreg Partners ) 2. Broken hyperlinks Validate links in an eCTD viewer; avoid absolute paths ClinReg article ( Clinreg Partners ) 3. Wrong sequence numbers Keep a dossier log; always build from the last approved sequence WAYS PS blog ( WAYS ) 4. XML envelope errors Use ePublishing software that auto-generates ZA envelope fields SAHPRA spec v3.1 ( ectd.sahpra.org.za ) 5. Portal upload failures Test a small file early; upload in business hours; keep help-desk details handy SAHPRA Q&A ( SAHPRA ) 6. Resource & training gaps Outsource to experts or arrange staff training on eCTD tools WAYS PS blog ( WAYS ) How MC Pharma Makes It Easy Turn-key compilation  – We convert, hyperlink and publish a compliant zip that passes SAHPRA validation first time. Pre-flight checks  – >400 automated rules verify PDF versions, MD5 hashes and filenames. Lifecycle management  – We track every sequence from registration to annual retention, variations and updates. Cross-market rollout  – MC Pharma possesses expertise to develop customised dossiers from SAHPRA recognised reference authorities (RRA's) such as the EMA, Health Canada, MHRA, TGA, the FDA, for submission across a number of countries in Africa, thereby facilitating a wider market access. Training & rescue  – Need a quick fix for a rejected dossier? Our regulatory team can step in immediately. Contact our Regulatory Affairs unit to discuss timelines and costs. Eight Key Take-aways eCTD is mandatory  for human-medicine and health product filings to SAHPRA. One dossier, many markets  – global regulators accept the same core Modules 2–5. Faster approvals  – electronic navigation trims review time. Built-in quality checks  reduce refusals for technical reasons. Clear lifecycle view  lets regulators see every change sequence-by-sequence. SA-specific Module 1  must follow the March 2024 v3.1 spec. (Regional) Common pitfalls are avoidable  with validation, sequence tracking and trained staff. MC Pharma offers end-to-end support , saving time, budget and stress. Frequently Asked Questions (FAQ) What is the eCTD?   A standard, hyper-linked electronic dossier accepted by most regulators worldwide. Is it mandatory in SA?   Yes—SAHPRA requires eCTD for all new submissions, variations and renewals ( ectd.sahpra.org.za ,  SAHPRA ) . Typical file size per sequence? Variations: a few MB; new registrations with study reports: 1–3 GB. Can I re-use my SA dossier for FDA? Yes—swap in the US Module 1; Modules 2-5 remain unchanged. MC Pharma baseline timeline? Two to four weeks, depending on document quality and volume. References ClinReg Partners. (2024, 26 December). Navigating the challenges of eCTD submissions: What to look for and how to overcome pitfalls .   https://www.clinregpartners.com  (Clinreg Partners) EFPIA eCTD Subgroup. (2021, 20 December). Global ICH eCTD adoption (white paper) .   https://www.efpia.eu  ( EFPIA ) International Council for Harmonisation. (n.d.). Electronic Common Technical Document specification v3.2.2 .   https://ich.org  ( ICH ) South African Health Products Regulatory Authority. (2024, March 11). ZA-SAHPRA eCTD specification v3.1 .   https://ectd.sahpra.org.za  ( ectd.sahpra.org.za ) South African Health Products Regulatory Authority. (2024, October 25). RIMS communication – eCTD Module 1 update .   https://www.sahpra.org.za  ( SAHPRA ) WAYS Pharmaceutical Services. (2024). The complexity of eCTD compliance: Common challenges and practical solutions .   https://www.waysps.com  ( WAYS ) SAHPRA. (n.d.). eCTD Submissions Portal .   https://ectd.sahpra.org.za  ( ectd.sahpra.org.za ) Contact MC Pharma for Your eCTD Needs Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction What is a NAPPI Code? Code Structure & Format Governance & Stakeholders Application Process & Timelines Benefits of Accurate Coding Common Pitfalls & How to Avoid Them MC Pharma's Support Services Practical Example Frequently Asked Questions References Introduction NAPPI  codes (National Pharmaceutical Product Index identifiers)  underpin every private-sector reimbursement claim in South Africa. Each seven-digit code, first six digits for the product, last three for the pack size, enables seamless electronic data exchange between manufacturers, pharmacies, funders and hospitals. Custodied by MediKredit and governed through the NAPPI Advisory Board, the system has been the single accepted product standard since the early 1990s. This article demystifies code structure, application pathways, common pitfalls, and shows where MC Pharma fits into the process from dossier compilation to medical-scheme engagement. What Is a NAPPI Code? A NAPPI code is a unique identifier for any pharmaceutical, surgical, medical-device or healthcare consumable product in South Africa’s private sector. The code facilitates price adjudication , stock control, claims switching and supply-chain analytics. NAPPI is the only product code recognised by all medical schemes and administrators when processing claims. Code Structure & Format Seven digits split 6-3   – the first six digits denote the specific product, while the last three digits indicate pack size (e.g., 712719-001). No therapeutic meaning  – unlike ATC or GMDN, the digits are purely numeric and sequential; therapeutic class is captured separately in pricing files. Governance & Stakeholders Entity Role MediKredit Allocates and maintains the master NAPPI file; publishes a daily public-domain extract. NAPPI Advisory Board (NAB) Industry forum of schemes, hospitals and clinicians providing oversight. Council for Medical Schemes (CMS) Issues guidance on correct coding for claim funding. Application Process & Timelines Determine eligibility  – only the local manufacturer or authorised importer may apply. Compile application pack  – This pack includes completed application form together with Ridout information such as PIL/PI, Artwork, price incl. and excl. VAT and more. Submit to MediKredit  – Submit the forms/documents and fee payable to MediKredit. NAPPI codes are usually issued within ten working days for straightforward items. Discovery / scheme review  – funders run health-technology assessments before confirming reimbursement; expect 6–10 days for surgical items and up to six months for novel technologies. Public-domain listing  – once approved, the code appears in the daily NAPPI file, enabling pharmacies to dispense and claim. Benefits of Accurate Coding Faster reimbursement  – correct codes prevent claim rejections and cash-flow delays. Transparent pricing   – uniform identifiers allow schemes to benchmark and manage reference-price lists. Regulatory data harmony  – NAPPI integrates with SAHPRA registration numbers and GMDN descriptors, streamlining audits. Common Pitfalls & How to Avoid Them Wrong pack digit trio  – mismatching pack size digits leads to pricing mismatches; always verify against the MediKredit search facility. Unregistered importer  – only the product’s legal holder may apply; third-party applications are rejected. Assuming automatic reimbursement  – a code enables billing but does not guarantee scheme funding; negotiate formularies separately. Contact our Regulatory Affairs unit to discuss how to avoid pitfalls. MC Pharma’s Support Services Gap analysis  – cross-check dossier, pricing and clinical evidence against NAB (NAPPI® Advisory Board) and Discovery requirements. Application drafting  – prepare NAPPI forms, documents that need to be attached and pricing spreadsheets. Scheme liaison  – engage PBM teams to secure formulary listing and agreed reference prices. Life-cycle maintenance  – monitor annual price-increase submissions and pack changes. Practical Example When FUTURELIFE ® Smart food™ (500 g) obtained NAPPI 712719-001 it became claimable under certain scheme rules, but reimbursement still depends on plan type and savings available. Frequently Asked Questions (FAQ) Who assigns NAPPI codes?   MediKredit Integrated Healthcare Solutions is the sole custodian and issuing authority. How long does it take to get a code?   Straightforward “me-too” items are typically coded within ten working days, while novel technologies may take longer due to funder HTA review. Do NAPPI codes guarantee reimbursement? No. A code enables electronic claims but each medical scheme decides whether—and at what rate—to fund the product. Can distributors apply on behalf of manufacturers? Only the local manufacturer or authorised importer (the highest authority in the supply chain) may lodge an application. What happens if my pack size changes? You must apply for a new three-digit pack suffix; using the wrong suffix will cause claim rejections. References Council for Medical Schemes. (2024). CMScript 10: Coding and funding of claims . ( medicalschemes.co.za ) Discovery Health. (2025). NAPPI code registration and review process 2025  [PDF]. MediKredit. (2024). NAPPI® – Products & Services page . ( medikredit.co.za ) MediKredit. (2024). NAPPI® code allocation policies and processes . ( medikredit.co.za ) National Pharmaceutical Product Index. (2024, 15 Feb). Wikipedia entry . ( en.wikipedia.org ) Competition Commission of South Africa. (2019). Health Market Inquiry submission – MediKredit  [PDF]. ( compcom.co.za ) Futurelife®. (2025). Certification – NAPPI code  page. ( futurelife.co.za ) Petsana, V. (2025, Jun). The NAPPI® system: South Africa’s unsung hero in healthcare  [LinkedIn Article]. ( linkedin.com ) MediKredit. (2025). NAPPI® search facility . ( medikredit.co.za ) Need assistance preparing your NAPPI application? Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction What is an SmPC and Why Does Compliance Matter? Global Regulatory Framework SmPC Structure at a Glance Compliance Life-Cycle Frequent Deficiencies & How to Avoid Them MC Pharma’s SmPC Compliance Services References Frequently Asked Questions Introduction to The Summary of Product Characteristics (SmPC) The SmPC is a critical, scientific, regulator-approved document that defines every authorised medicine’s benefits, risks and conditions of use. The SmPC is synonymous with the South African Professional Information (PI) leaflet which is regulated in terms of Regulation 11 of Act 101/1965 (The Medicines and Related Substances Act).   The SmPC follows the format stipulated by the European Medicines Agency (EMA) Directive 2001/83/EC (2025). What is an SmPC and Why Does Compliance Matter? The SmPC is a critical (and legal) part of the registration application for every medicine. It is an integral part of the registration application and is presented in Module 1.3. of the Common Technical Document (the CTD).  The SmPC must be aligned and referenced against CTD Modules 2 -5 and SAHPRA’s Guidelines. The SmPC is subject to review and registration approval by SAHPRA.  It serves as the master document upon which patient leaflets and promotional claims are based. Non-compliant SmPCs will result in regulatory findings or even rejection of the medicine’s application. Global Regulatory Framework South Africa & SADC & the WHO SAHPRA adopts a tripartite model: SmPC (called the package insert), patient leaflet and outer labelling, aligned with a 13-section structure derived from EU rules. ( sahpra.org.za ). The WHO promotes reliance, harmonisation, and SmPC alignment across regions like SADC, EAC, and ZAZIBONA The European Union Directive 2001/83/EC (Article 11) lists the mandatory headings and legal status of the SmPC. ( eur-lex.europa.eu ) EMA’s Quality Review of Documents (QRD) template  sets standard wording ; v11 is now in public consultation (deadline 31 Aug 2025). The upcoming ePI system ( electronic Product Information) is a digital, standardised version of the SmPC, PIL (Patient Information Leaflet), and labelling—structured in machine-readable XML format instead of traditional PDFs or Word files. This XML format will allow for: Searchable and filterable content Integration into electronic health records (EHRs) Automated updates Accessibility for mobile and web applications SAHPRA has not yet aligned to the ePI, and may adopt similar digital standards over time . The United Kingdom The MHRA retains the EU QRD headings but applies its own labelling and packaging best-practice guidance post-Brexit. ( gov.uk ,   assets.publishing.service.gov.uk ) Approved UK SmPCs are published on the MHRA Product Information Portal. SmPC Structure at a Glance The SmPC Structure is  based on the EMA QRD template , widely adopted and adapted by SAHPRA and many WHO-aligned regulatory authorities: Section Title Purpose “Scheduling Status” to appear above Section 1 1 Name of the Medicinal Product Name, strength & dosage form 2 Qualitative and Quantitative Composition API content & excipients of known effect 3 Pharmaceutical Form Description (e.g., tablet, solution) & appearance 4.1 Therapeutic Indications Approved medical uses 4.2 Posology and Method of Administration Dosing regimen & administration instructions 4.3 Contraindications Conditions or factors that prohibit use 4.4 Special Warnings and Precautions for Use Key safety risks and precautions 4.5 Interaction with Other Medicinal Products and Other Forms Known or expected drug interactions 4.6 Fertility, Pregnancy, and Lactation Use considerations in these groups 4.7 Effects on Ability to Drive and Use Machines Safety information regarding psychomotor skills 4.8 Undesirable Effects (Adverse Reactions) Side effects with frequencies 4.9 Overdose Signs, symptoms, and management 5.1 Pharmacodynamic Properties Mechanism of action & therapeutic class 5.2 Pharmacokinetic Properties ADME profile (Absorption, Distribution, Metabolism, Excretion) 5.3 Preclinical Safety Data Toxicology and safety in animals 6.1 List of Excipients All non-active ingredients 6.2 Incompatibilities Known incompatibilities with other substances 6.3 Shelf Life Duration of product stability 6.4 Special Precautions for Storage Storage conditions (e.g., refrigeration) 6.5 Nature and Contents of Container Packaging material and configuration 6.6 Special Precautions for Disposal Safe disposal and handling instructions 7 Marketing Authorisation Holder (MAH) Name and address 8 Marketing Authorisation Number(s) Regulatory reference numbers 9 Date of First Authorisation/Renewal Historical regulatory data 10 Date of Revision of the Text Last update to SmPC 11 Dosimetry   (radiopharmaceuticals only) Radiation exposure details Compliance Life-Cycle SmPC (or Professional Information/PI in SAHPRA terms) compliance is not static—it's a life-cycle obligation that spans from product development to post-marketing. Here’s a structured view of the key compliance aspects throughout the SmPC life-cycle: Initial Registration & Approval SmPC must be technically validated and complete at submission. SAHPRA requires the SmPC (PI) to form the basis for the PIL. Scientific, unambiguous, and non-promotional language is mandatory. Excipient listings, shelf life, dosage forms, and manufacturer details must match other dossier modules. Post-Registration Maintenance (Variations & Updates) SmPC must be updated to reflect new safety data (e.g. pharmacovigilance, clinical literature). All clinical and safety updates (new indications, contraindications, adverse effects) require Type II variation applications. For reliance-based submissions, SmPC updates must align with recognised reference authorities. Renewals & Retention Renewal submissions must confirm that the SmPC remains current and accurate. Retention Requirements Retention of registration every five years includes compliance check of SmPC accuracy and consistency. Pharmacovigilance-Linked Obligations Adverse event trends must trigger updates in SmPC Section 4.8 (Undesirable Effects). Risk Management Plans (RMPs) Must inform and align with SmPC content (e.g. Section 4.4: Warnings and Precautions). Frequent Deficiencies & How to Avoid Them Deficiency Possible Root Cause Fix Safety class warnings missing Copy/paste from originator PI without updates or incorrect references used Requires a detailed review and a line-by-line gap analysis against the reference SmPC. Mis-aligned SPC/PIL text Different persons working of the document and no final document checks or validation. Maintain single‐source master documents and references in RIM tools Cross-referenced non-existing studies Poor document control List only peer-reviewed or regulator-accepted references.  MC Pharma’s SmPC Compliance Services Medical writing & SmPC authoring  – drafting de-novo or generic SmPCs against SAHPRA templates and guidelines. Regulatory gap analysis  – identifying wording misalignments and reference to approved Reference materials. Variation strategy  – classifying the variations and preparing the application and submission package Life-cycle maintenance  – continuous surveillance of literature and safety data to trigger timely updates. Frequently Asked Questions (FAQ) What is the legal status of an SmPC?   It is part of the marketing authorisation and its wording is legally binding. Do SAHPRA and EMA use the same headings? Yes – SAHPRA mirrors the EU QRD headings with minor local tweaks. When is a Type II variation required? For major safety or efficacy updates, new indications, posology changes, or new safety and efficacy data. How long does a Type IB variation take? 30 + 7 working days clock-in-hand, plus clock-stops if questions arise. Can marketing claims exceed the SmPC? No – promotional materials cannot go beyond the SmPC wording. How does MC Pharma support SmPC updates? We classify the variation, draft the updated text, submit through e-submission portals and track approval. Is the SmPC the same as the patient leaflet? No – the SmPC is for healthcare professionals; the PIL is derived from it for patients. References European Medicines Agency. (2025). Product-information (QRD) templates – draft v11 . ( ema.europa.eu ) European Medicines Agency. (2023). Electronic product information (ePI) pilot page . ( ema.europa.eu ) European Medicines Agency. (2024). ePI pilot report – lessons learned . ( ema.europa.eu ) European Medicines Agency. (2024). Assessment guide for SmPC Section 5.1 . ( ema.europa.eu ) European Commission. (2024). Draft Variations Classification Guideline . ( health.ec.europa.eu ) European Commission. (2009). Guideline on the SmPC (EudraLex Vol 2C) . ( health.ec.europa.eu ) Directive 2001/83/EC of the European Parliament and Council. (2001). Community code relating to medicinal products for human use . ( eur-lex.europa.eu ) Medicines and Healthcare Products Regulatory Agency. (2020). Best-practice guidance on labelling & packaging . ( assets.publishing.service.gov.uk ) GOV.UK . (2024). Medicines: Packaging, labelling and PIL  (MHRA overview). ( gov.uk ) Royal Pharmaceutical Society. (2025). Overview of SmPCs for trainee pharmacists . SAHPRA. (2022). Clinical Evaluation Guideline (SmPC equivalent) . ( sahpra.org.za ) SAHPRA / SADC. (2019). Draft Guideline on Product-Information & Labelling . ( sahpra.org.za ) World Health Organization. (2024). Contents & structure of a WHOPAR . ( extranet.who.int ) EMA PLM Portal. (2024). ePI user guide for applicants . ( plm-portal.ema.europa.eu ) Need a gap analysis or XML conversion for your next SmPC submission? Why choose MC Pharma? With over 26 years  of experience in navigating South Africa’s complex regulatory landscape, MC Pharma  is your strategic partner for patient safety , regulatory excellence , and market success . 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website

Table of Contents Introduction Registered Medicine vs Medical Device The Acid Test of Whether A Product Is A Medicine or Medical Device Registration as A Medicine | Classification of A Device Current Registration Requirements For The Product Registration Call-Up Plan For Medical Devices Borderline Products (Ref SAHPRA Guideline 2.45) Bonusing and Sampling – Sections 18A and 18B of Act 101/1965 SEP (Single Exit Pricing) Advertising Restrictions General Legislation of Application: Consumer Protection Act (No 68 of 2008): A Measure of Risk Summary - In Terms of Current Regulations Frequently Asked Questions References How MC Pharma Provides Services & Consulting Introduction The purpose of this communication is to help you differentiate important aspects that define what is a registered medicine and what is a combination medical device. Medical Device regulation and registration in South Africa and in fact Southern Africa is in its infancy and product registration policies are still being developed by the Regulators in these regions. This summary of regulatory requirements and conditions is a motivation in support of registered medicines and prepared in defense of routine therapeutic substitution of a combination medical device for a registered medicine. We argue that a registered medicine, with reference to its therapeutic indication, cannot be routinely substituted with a combination medical device. Registered Medicine vs Medical Device Let's Start With Definitions – Refer Act 101/1965: Definition of A Medicine (a) means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in— (i) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the symptoms thereof in humans; or (ii) restoring, correcting or modifying any somatic or psychic or organic function in humans. Definition of A Medical Device Means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, ..[…] (b) which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means; The intention of medical devices are for one or more of the following: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; or providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body. which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means. The Acid Test of Whether A Product Is A Medicine or Medical Device The acid test of whether something is or is not a medical device or an IVD is: what is it used for and how does it work? The "how" is important because for something to be a medical device, it cannot achieve its primary intended action by pharmacological, immunological or metabolic means (so a medical device is not a drug or vaccine, for instance). These processes could support the intended functioning of a medical device but would not be the main activity. This narrows down the possibilities somewhat, but the potential range is still extremely wide. If the function of an instrument, apparatus, implement, machine, implant, software and the like is intended by the manufacturer to diagnose, prevent, monitor, treat or alleviate disease, then it is a medical device. If it is intended to diagnose, monitor, treat, alleviate or compensate for an injury, it is a medical device. The same applies if it is intended to control conception, disinfect medical devices, or support or sustain life. It is also a medical device if it is meant to investigate, replace, modify or support the anatomy or a physiological process. All in all, the definition of a medical device is so wide that it has some industry watchers wondering whether it includes devices such as fitness trackers, which measure the wearer's personal fitness by monitoring various factors such as heart rate, steps walked, and calories consumed. Chances are that such items are not medical devices as long as they only provide data for the edification of the wearer. If used for any form of diagnostics or treatment, however, then it arguably crosses the line into medical device or IVD territory. An item that almost certainly is a medical device is a blood-glucose monitor that people with diabetes might use to inform them when to take their medication. Another example is an app that sends an emergency signal in the event of a stroke, heart attack or other health crisis. Registration as A Medicine | Classification of A Device Medicines in South Africa are subject to a system of scheduling on the basis of the active pharmaceutical ingredients that they contain. The primary consideration in scheduling a substance is its safety profile, in relation to the therapeutic indications for its use. Devices are a self-assessment by the licensed Applicant based upon a set of classification rules supplied by the Regulatory Authority, based on: the manufacturers or distributor’s intended use of the device or IVD; level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm); degree of invasiveness in the human body; and duration of use and exposure. The Regulatory Authority has the responsibility and authority to determine the final classification. According to SAHPRA Guidelines medical devices are classified into the following four risk classes, determined according to published classification rules: Class A – Low Risk Class B – Low-Moderate Risk Class C – Moderate-high Risk Class D – High Risk Where risk relates to the patient, user or to public health. The highest risk devices are those that are implantable or invasive and are used in the long term. Current Registration Requirements For The Product Registered Medicine Medicines are required to be fully registered with SAHPRA (South African Health Products Authority) before they are authorized for sale in South Africa. The SAHPRA registration process includes a scientific review of all aspects of quality, safety and efficacy for the product and marketing authorization is conditional on the Applicant meeting the strict SAHPRA Licensing standards for all partners in the supply chain, including Licensed Distributors/Wholesalers. The conditions of registration also include stringent product quality management control, such as pharmacovigilance, post-importation quality analysis, validation of transportation, on-going stability testing, the provision of product quality review reports etc. Medical Device At this moment, there is no registration procedure for medical devices – this is still in development with a call-up program imminent, based upon a risk assessment – which means that Class D medical Devices will be called up first. Registration Call-Up Plan For Medical Devices Although, the Medicines Act and General Regulations provides for the above, SAHPRA’s registration process is currently in development. To ensure its mandate that medical devices are safe, effective and of good quality, when SAHPRA registers medical devices, it must "call-up" specific products or product classes for registration by publishing a call-up notice in the Government Gazette. A draft call-up plan outlines the steps involved in this process. It explains that SAHPRA will use a risk-based approach in calling up medical devices for registration, prioritising the registration of more risky products and products of public health importance. Product call-ups will cover medical devices that are already on the market in South Africa as well as new medical devices that are being introduced. In the absence of medical device registration, SAHPRA has established several "quasi-registration" requirements as part of its medical device establishment licensing processes to enable oversight and control of medical devices used in South Africa. In March 2024, SAHPRA invited the industry to submit an Expression of Interest (EOI) to take part in a Feasibility Study (NOT PILOT STUDY) for the registration of medical devices. Borderline Products (Ref SAHPRA Guideline 2.45) “ Health products which cannot be classified as either a pharmaceutical, medical device, cosmetic, food supplement, or biocidal product because they are indistinguishable from one another are referred to as "borderline" products until SAHPRA determines their categorisation status and assigns them to a specific regulatory pathway. SAHPRA issued a [Borderline] guideline in 2017 to provide applicants with recommendations regarding the registration of borderline and combination products. However, the guideline, which proposes the framework discussed below, has not yet been finalised.” Determination of whether a product is a Medicine or Medical Device will consider the following: The primary mode of action (PMOA) means “the single mode of action of a borderline product that provides the most important therapeutic action of the borderline product.” The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended therapeutic effect(s) of the borderline product. The claimed effect or purpose must be achieved by the most important therapeutic action. Where the primary intended mode of action is achieved by pharmacological, immunological or metabolic means, in or on the human or animal body, the borderline product is designated to be a medicine: Immunological  – understood as an action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction. Metabolic  – understood as an action which involves an alteration of the normal chemical processes participating in, and available for, normal body function. The fact that a product is itself metabolized does not imply that it achieves its principal intended action by metabolic means. Pharmacological  – understood as an interaction between the molecules of the substance in question and a cellular constituent, usually referred to as a receptor, which either results in a direct response, or which blocks the response to another agent and, for the purposes of this policy, includes anti-infective activity. Where the primary intended mode of action is achieved by pharmacological, immunological or metabolic means, and the action occurs in vitro, without reintroducing a modified cellular substance to the patient, the product will be designated to be a medical device. Where the primary intended mode of action by which the claimed effect or purpose is not achieved by pharmacological, immunological, or metabolic means, but may be assisted in that effect or purpose by pharmacological, immunological, or metabolic means, the borderline product (including a combination product) will be designated to be a medical device. A borderline product may be classified as a medicine or a medical device, even when no explicit therapeutic claim is made. A therapeutic claim may also be implicit. Both types of claims are considered when a product is classified. Explicit claims are stated with no ambiguity with regard to their meaning or intent. In contrast, implicit claims made in the representation of a product indirectly suggest a therapeutic benefit. Product representation includes the appearance, labelling, and advertising of a product. In the absence of either an explicit or implicit claim, a product may be classified (e.g., as a medicine or a medical device) if the intrinsic properties of the product are such that there is no other possible use. For example, acetaminophen (paracetamol) has no other use but as a medicine, so the absence of a claim will not change its classification as a medicine. In addition to the primary mode of action – the composition and form of the product and the therapeutic effect of the product may be considered to assist in the designation of the product. The composition and form of a product may help to distinguish a medicine from a medical device. A medical device exhibits structure in its final therapeutic form, that is, the structure of the product when it is achieving its effect. With a medical device, its structure contributes directly to its effect. In contrast, the physical structure of a medicine (that is, in its dosage form, such as a tablet or an ointment, not its chemical structure) does not usually contribute directly to its therapeutic effect. Consideration is also given to the therapeutic effect of a product and how this effect is achieved. In Act 101, as amended, the definition of a medicine and medical device differ respectively in whether a product is used to restore, correct or modify any somatic or psychic or organic function (as with a medicine) OR treat or alleviate a disease; treat, alleviate or compensate for an injury, or modify or support of the anatomy or of a physiological process (as with a medical device). Bonusing and Sampling – Sections 18A and 18B of Act 101/1965 Registered Medicine 18A. Bonusing:  Prohibits the supply of any medicine, medical device or IVD according to a bonus system, rebate system or any other incentive scheme. 18B. Sampling:  Prohibits sampling of any medicine, medical devices or IVD. “For the purposes of this section ‘sample’ means the free supply of products, medical devices or IVDs by a device or IVD establishment, manufacturer or wholesaler or its agent to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974.” This includes consignment stock. Medical Device Although Medical Devices are referred to in Sections 18A and 18B of Act 101/1965, Medical Devices currently have a temporary exemption from these sections in the Act, by means of a three-year Section 36 exemption notice. SEP (Single Exit Pricing) The Medicines Act provides for a transparent pricing system which incorporates a single exit price (SEP) for medicines and scheduled substances. The SEP is the price at which manufacturers (including importers) are required to sell medicines and scheduled substances to anyone other than the government. A pharmacy, wholesaler, distributor, or any person licensed under the Medicines Act is prohibited from selling a drug for more than the prescribed SEP. However, pharmacists may charge an appropriate dispensing fee based on the recommendations of the Pricing Committee. This is, however, regulated by Section 22C of the Medicines Act. Registered Medicine Applicable to Medicines - The pricing breakdown of medicines is transparent and is regulated. These prices are published on the Department of Health website. Annual increases are pre-set and pre-determined and published annually in the Government Gazette. Only one SEP increase is permitted annually. Medical Device Currently and temporarily not applicable to Medical Devices – temporary exemption granted. Medical Device prices may be fluctuated and changed according to market needs. There are no regulatory restrictions on the pricing of Medical Devices. Advertising Restrictions Registered Medicine S2 to S4 may only be advertised to the healthcare professions. Medical Device Class D may only be advertised to the Profession.  Medical devices are not permitted to market in South Africa unless they are listed in the South African Medical Device Register. The CPA predominantly sets out the requirements for advertising and marketing of products and services (general, medical or otherwise). The CPA requires that the advertising and marketing of goods is to be done in a manner that is not reasonably likely to imply a false or misleading representation concerning those goods and is not misleading, fraudulent or deceptive in any way. With respect to claims, suppliers are warned in the CPA that strict liability will be imputed onto producers, importers, distributors or retailers of any goods on which inadequate instructions or warnings are provided to the consumer relating to any hazard arising from or associated with the use of the goods. General Legislation of Application: Consumer Protection Act (No 68 of 2008): A Measure of Risk In South Africa, product safety in general is governed by the Consumer Protection Act (No 68 of 2008) (the CPA). The CPA provides for the promotion of a fair, accessible and sustainable marketplace for consumer products and services and for that purpose, establishes national norms and standards relating to consumer protection, provides for improved standards of consumer information, prohibits certain unfair marketing and business practices, promotes responsible consumer behaviour, and promotes a consistent legislative and enforcement framework relating to consumer transactions and agreements. This consequently creates an obligation on suppliers of products (from the beginning to the end of a supply chain) to provide healthcare products and medical devices free of defects. The CPA imposes strict liability on producers or importers, distributors or retailers for any harm caused by a product (which would include medical devices) caused wholly or partly as a consequence of: supplying unsafe goods; a product failure, defect or hazard in any goods; or inadequate instructions or warnings provided to the consumer pertaining to any hazard arising from or associated with the use of any goods, irrespective of whether the harm resulted from any negligence on the part of the producer, importer, distributor or retailer, as the case may be. Summary - In Terms of Current Regulations: Medical Device establishments are required to be SAHPRA Licensed. There is no formal SAHPRA registration procedure for medical devices as yet. A Borderline Medical Device containing active chemical substances: does not achieve its primary intended action by pharmacological means/action. The pharmacological action of active ingredients in borderline medical devices is secondary and auxiliary to the primary indication of hemostasis. Medicine is supported by vast clinical studies, experience and knowledge that backs the brand as well as the medicinal registration status. Quality and Efficacy of Medicines throughout the distribution chain is assured by means of comprehensive Quality Management systems that are SAHPRA audited. These systems require validation throughout manufacturing, stability, transportation, post-importation quality analysis, Release procedures, distribution, marketing/sales and pharmacovigilance. Frequently Asked Questions (FAQ) What is the primary difference between a medicine and a medical device? A medicine achieves its primary intended action through pharmacological, immunological, or metabolic means, while a medical device achieves its main effect through physical or mechanical means, potentially supported by pharmacological action. How are medicines regulated in South Africa? Medicines must be fully registered with SAHPRA, undergo scientific review for quality, safety, and efficacy, and comply with strict licensing, pharmacovigilance, and supply chain quality standards. How does SAHPRA classify medical devices? Medical devices are classified into four risk-based categories — Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk) — based on intended use, invasiveness, duration of use, and potential risk to the patient. Is pricing regulated for medical devices in South Africa? No. Medical devices are exempt from single exit price (SEP) regulations, meaning their prices can vary based on market factors without regulatory restrictions. What is a borderline product? A borderline product is one that cannot easily be classified as a medicine, medical device, cosmetic, food supplement, or biocidal product. SAHPRA determines its classification based on its primary mode of action and intended purpose. References Bowmans. South Africa: Regulation of Medical Devices is Set to Become a Reality in SA , Julie Oppenheim, 30 September 2020. - https://bowmanslaw.com/insights/regulation-of-medical-devices-is-set-to-become-a-reality-in-sa/ MCC (SAHPRA) Guideline 2.45 on Borderline Products, March 2017. - https://www.mbac.co.za/wp-content/uploads/2019/10/2.45-Borderline_Products_Feb17_v1_for_comment.pdf  ( mbac.co.za ) Regulations Relating to Medical Devices and In-vitro Diagnostic Medical Devices (IVDs), Government Gazette No 40480, 9 December 2016 (Regulation 11(1)). URL (Gazette reference provided via SAHPRA site): https://www.sahpra.org.za/medical-devices/  ( SAHPRA ) Medical Devices and Consumer Health Products 2021; Fasken Law Practice, 31 August 2021. (No current URL found—this appears to be a law firm publication not indexed publicly.) SAHPRA publication; ITG Meeting update, November 2021. Status of Guideline 2.45 (Borderline Products) – Comments under review. (No direct URL located; likely internal or unpublished doc.) SAHPGL-MD-04_v5 – Guideline for Classification of MD and IVDs. URL: https://www.sahpra.org.za/document/guideline-for-classification-of-medical-devices-and-ivds/  ( SAHPRA ) Essential Principle Compliance – Medical_Device_IVD_Essential_Principles_Nov19_v2 . URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/  (link includes Essential Principles doc) ( SAHPRA ) GUIDELINE FOR MEDICAL DEVICE VIGILANCE: Adverse Events Reporting – SAHPGL-MD-03_v4. URL: https://www.sahpra.org.za/document/guideline-for-medical-device-adverse-event-reporting/  ( SAHPRA ) SAHPGL-MD-11_v1 – Guideline for Completing Medical Device Adverse Event Form. URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/  (the listing page includes MD‑11 doc) ( SAHPRA ) GLF-MD-11A_v1 – Medical Device Adverse Event Reporting Form. URL: https://www.sahpra.org.za/medical-devices-and-in-vitro-diagnostics-guidelines/  ( SAHPRA ) Guideline for Completing Medical Device Adverse Event Form – SAHPGL-MD-11_v1. Medical Device Establishment Licence Renewal Process. - https://www.sahpra.org.za/document/md031-medical-device-establishment-licence-renewal-process/  ( SAHPRA ) How MC Pharma Provides Services & Consulting As a licensed Marketing Authorisation Holder (MAH)  under Section 22C of the Medicines and Related Substances Act, MC Pharma offers end-to-end regulatory consulting and compliance support for both medicines and medical devices in South Africa. Our services include: Regulatory Affairs Consulting  – Guiding clients through SAHPRA requirements, classification, and registration strategies. eCTD Dossier Management  – Compilation, publishing, submission, and lifecycle management of regulatory dossiers. Pharmacovigilance  – Monitoring, reporting, and managing adverse events to ensure ongoing safety compliance. Borderline Product Support  – Assisting with classification assessments and preparing submissions for SAHPRA determination. Import & Export Logistics  – Managing compliant movement of medicines and devices across borders, including post-importation quality testing. Quality Management Systems  – Developing, implementing, and auditing QMS to SAHPRA standards. Why Choose MC Pharma? MC Pharma combines over 26 years of regulatory experience  with a deep understanding of the South African pharmaceutical and medical device landscape to deliver compliant, efficient, and market-ready solutions for local and international clients. 📞 +27 (012) 668 3019  ✉️ pharmacist@mcpharma.co.za   🌐   Visit our website