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Pharmaceutical Industry News
Your Trusted Source for Pharma Industry News
Explore a wealth of Pharmaceutical Regulatory Industry News, encompassing policy changes, regulatory advancements, and industry trends, curated meticulously to provide you with a reliable source of latest updates.
Frequently asked questions
Pharmaceutical Industry News
To anticipate regulatory changes, identify market trends, and ensure proactive compliance.
Yes, MC Pharma shares industry insights and regulatory intelligence regularly.
SAHPRA regulations, international regulatory changes, GMP updates, pharmacovigilance guidelines.
Timely industry news allows companies to adjust quickly to regulatory changes and maintain compliance.
Yes, MC Pharma offers tailored regulatory intelligence and updates to clients based on their industry and market needs.
All Posts
International Dossier Evaluation – Streamlining Global Submissions
International Dossier Evaluation unpacks the global rules for CTD/eCTD files, reliance reviews, and the African context - plus how MC Pharma guides applicants from gap analysis to life-cycle management.
Dec 19, 20254 min read
Regulatory Affairs in African Pharma – Compliance, SAHPRA & Market Entry
Regulatory Affairs sits at the intersection of science, law and patient safety. It governs how medicines and medical devices are developed, authorised and maintained throughout their lifecycle. From SAHPRA submissions and regulatory strategy to authority interactions and post approval compliance, this infographic outlines the core pillars of regulatory affairs and shows how MC Pharma supports compliant market access in South Africa and across Africa.
Dec 19, 20257 min read
Navigating SAHPRA: A Comprehensive Guide by MC Pharma
An in-depth guide for industry professionals on the South African Health Products Regulatory Authority (SAHPRA), covering its mandate, structure, core functions (product registration, licensing, clinical trials, pharmacovigilance), market impact, and compliance strategies. Essential reading for navigating South Africa's health product landscape.
Dec 17, 202513 min read
MC Pharma Successfully Audited by Pharmalane UK for GDP & Pharmacovigilance
On 11 March 2025, MC Pharma completed a one-day remote GDP & pharmacovigilance audit by Pharmalane UK. The April 2025 Audit Compliance Report was accepted and the audit is formally closed. This additional, independent review reinforces MC Pharma’s existing approvals and provides partners with further assurance around EU-aligned GDP controls and robust PV governance.
Dec 11, 20255 min read
Funky Socks Day 2025: South Africa and Namibia Step Up for Change
Today, 12 September, South Africa and Namibia wear funky socks to raise funds for vulnerable children. Stickers cost R10/N$10, with proceeds supporting Breadline Africa, CHOC, Rally to Read, and Matla a Bana. Join the movement and make your steps count for literacy, ECD, and child protection.
Sep 12, 20253 min read
Medicine vs Medical Device - Key Regulatory Differences in South Africa
Discover the key differences between medicines and medical devices under South African law.
Learn how each is defined, regulated, classified, and priced and how MC Pharma can support your compliance.
Sep 2, 202513 min read
SmPC Compliance – Getting Product Information Right
From initial authoring to Type IB variations and ePI XML, this guide demystifies SmPC compliance and shows how MC Pharma keeps your product information aligned with global standards.
Aug 8, 20256 min read
NAPPI Codes – How to Obtain & Use Them
NAPPI codes are the healthcare industry’s universal product IDs for medicines, devices and consumables. Learn how they work, how to apply, and how MC Pharma speeds up your reimbursement journey.
Jul 17, 20254 min read
eCTD Guide for South African Medicine & Health Product Submissions
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.
Jun 20, 20254 min read
MC Pharma Celebrates 26 Years of Regulatory Excellence as Silver Sponsor at SAPHEX 2025
MC Pharma and partner company Mnandi Pharma proudly sponsored SAPHEX 2025. Discover our 26-year journey, what SAPHEX offers, and how to book for 2026.
May 30, 20253 min read
Pharmacovigilance in South Africa: How MC Pharma safeguards your safety.
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.
Apr 22, 20253 min read
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