Regulatory Blog

The Early Access to Medicines Scheme (EAMS)  is a regulatory initiative in the United Kingdom designed to provide patients with life-threatening or seriously debilitating conditions earlier access to promising medicines before full marketing authorisation is granted. The scheme is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) and aims to accelerate patient access to innovative treatments where there is a clear unmet medical need. The main obj

South Africa continues to strengthen regulatory efficiency and regional collaboration through structured reliance pathways. The SAHPRA Medical Devices Reliance Guideline and the ZAZIBONA Centralised Procedure – SAHPRA’s Reliance Process  collectively demonstrate SAHPRA’s commitment to regulatory convergence within the SADC region. Guidance: Medical Devices Reliance Guideline – SAHPRA’s Structured Reliance Framework The Medical Devices Reliance Guideline outlines the principle

In February 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry outlining considerations for using a Plausible Mechanism Framework  to develop individualized therapies that target specific genetic conditions with a known biological cause. The draft guidance, developed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), describes how developers may generate substantial evidence o