Pharmaceutical Industry News

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.

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.

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.

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.

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.

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.

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.

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.