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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

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.

Knowledge Hub

Access practical tips, how-to guides, regulatory resources, and expert advice to navigate pharmaceutical market entry and compliance.

Globe covered with international country flags representing global regulatory affairs and international dossier submissions

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.

Knowledge Hub

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.

Knowledge Hub

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.

Knowledge Hub

Dec 17, 202513 min read

Medicine vs Medical Device cover banner highlighting South Africa’s key differences with tablets, capsules and a patient monitor.

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.

Knowledge Hub

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.

Knowledge Hub

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.

Knowledge Hub

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.

Knowledge Hub

Jun 20, 20254 min read

Various blue and white pills and capsules on a glass surface. Medical icons float above. Background features a blue lab setting.

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.

Knowledge Hub

Apr 22, 20253 min read

Latest Insights and Updates

Pharmaceutical Industry News

Your Trusted Source for Pharma Industry News

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Knowledge Hub

International Dossier Evaluation – Streamlining Global Submissions

Regulatory Affairs in African Pharma – Compliance, SAHPRA & Market Entry

Navigating SAHPRA: A Comprehensive Guide by MC Pharma

Medicine vs Medical Device - Key Regulatory Differences in South Africa

SmPC Compliance – Getting Product Information Right

NAPPI Codes – How to Obtain & Use Them

eCTD Guide for South African Medicine & Health Product Submissions

Pharmacovigilance in South Africa: How MC Pharma safeguards your safety.

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