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.
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 guide outlines the core pillars of regulatory affairs and shows how MC Pharma supports compliant market access in South Africa and across Africa.
Expert guide by MC Pharma on navigating SAHPRA regulations in South Africa. Understand mandates, processes & compliance for health products.
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.
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.
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.
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.
MC Pharma supports pharmacovigilance in South Africa. Ensure patient safety, comply with SAHPRA regulations, and implement risk management effectively.
To anticipate regulatory changes, identify market trends, and ensure proactive compliance.