Regulatory Blog

The Medicines and Healthcare products Regulatory Agency (MHRA) provides an online portal that enables organisations and individuals to submit regulatory forms and manage applications electronically. The MHRA Portal is designed to streamline regulatory submissions, improve efficiency, and provide a centralised system for interacting with the agency. This guidance explains how users can register for the MHRA Portal, outlines the registration process, and describes key considera

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