Navigating SAHPRA: A Comprehensive Guide by MC Pharma

Table of Contents

1. Introduction

2. Understanding SAHPRA: South Africa's Health Products Regulator

3. Core Regulatory Functions of SAHPRA

4. The Impact of SAHPRA on the South African Health Product Landscape

5. Navigating SAHPRA Regulations: Guidance for Industry Professionals

6. Partnering for Compliance: How MC Pharma Can Assist

7. Frequently Asked Questions (FAQs) about SAHPRA

8. Footnotes

9. Works Cited

10. 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

1. What are the main differences between SAHPRA and the old MCC?

   1. 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.

2. How long does product registration typically take with SAHPRA?

   1. 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.

3. Does SAHPRA regulate medical devices and diagnostics?

   1. 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).

4. Can I use my FDA/EMA approval to register my product in South Africa?

   1. 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.

5. Where can I find the latest SAHPRA guidelines and fee schedules?

   1. 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.

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