Regulatory Blog

The US Food and Drug Administration (FDA) has issued its final guidance, Potency Assurance for Cellular and Gene Therapy Products, providing recommendations for developing a science- and risk-based strategy to ensure the potency of cellular and gene therapy (CGT) products. The guidance supersedes the January 2011 guidance on potency tests and introduces a comprehensive approach integrating manufacturing process design, material controls, in-process testing and potency assays

The European Medicines Agency (EMA) has revised its Questions and Answers guidance for marketing authorisation holders (MAHs) and applicants on nitrosamine impurities in human medicinal products. Revision 24, dated 3 November 2026, introduces important clarifications on acceptable intake (AI) limits, less-than-lifetime (LTL) exposure, other N-nitroso compounds and nitrosamines originating from excipients. The update also revises existing recommendations on risk factors, contr

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated two guidance documents covering Good Clinical Practice (GCP) inspections for medicinal product clinical trials and clinical investigations for medical devices. Both guidance documents were updated on 6 November 2026, providing information on regulatory compliance, inspection procedures, application requirements and clinical investigation responsibilities. 1. Clinical Trials for Medicines: Good Clinical

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on using non-clinical data generated outside the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) framework to support UK Clinical Trial Authorisation (CTA) applications. OECD MAD (Mutual Acceptance of Data) is an international agreement under which participating countries accept data generated in accordance with OECD Test Guidelines and OECD Prin