The EPR regulatory roundup: 2–6 November 2026

Welcome to the inaugural edition of our weekly regulatory roundup, covering the latest regulatory updates from around the world. This week, developments include revised European guidance on nitrosamine impurities, new US recommendations for cell and gene therapy potency assurance and updated UK guidance on non-clinical safety data.

EMA updates Q&As on nitrosamine impurities

The European Medicines Agency (EMA) has updated its question-and-answer (Q&A) document on nitrosamine impurities in human medicines, introducing several changes to existing recommendations for marketing authorisation holders. These include extending the implementation period for corrective and preventive actions (CAPAs) from three to seven years under certain conditions, and introducing higher acceptable intake (AI) limits through the full application of the less-than-lifetime (LTL) approach outlined in ICH M7 for eligible medicines intended for treatment durations of less than 10 years. The revised Q&As also recognise a new risk factor for nitrosamine formation linked to parenteral products packaged in polymer bags. The revised Q&As also clarify how acceptable intake limits can be established for other N-nitroso compounds and nitrosamines originating from excipients.

FDA finalises cell and gene therapy potency guidance

The US Food and Drug Administration (FDA) has issued final guidance outlining a science- and risk-based approach to potency assurance for cellular and gene therapy (CGT) products. Replacing its previous 2011 guidance, the recommendations cover the product lifecycle, from early development and investigational applications through commercialisation and post-approval monitoring. The FDA highlights the importance of integrating potency considerations throughout manufacturing, including controls for raw material variability, testing during manufacturing and laboratory assays to confirm that each batch is biologically active in a way that matches its intended therapeutic effect. The guidance also addresses specific considerations for viral vector therapies and patient-specific products, providing manufacturers with a framework for demonstrating consistent product potency.

MHRA establishes framework for non-OECD non-clinical safety data

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance establishing a risk-proportionate and patient-centred framework for considering non-clinical data generated outside the Organisation for Economic Co-operation and Development (OECD) Mutual Acceptance of Data (MAD) framework in support of clinical trial authorisation (CTA) applications. The framework aims to support the development of innovative medicines, particularly those addressing serious diseases and significant unmet medical needs, while maintaining participant safety and scientific integrity. The framework comprises three complementary streams: inspection and compliance intelligence, enhanced non-clinical assessment, and a weight-of-evidence use of clinical data. The initial scope of the enhanced assessment pathway focuses on first-in-human trials in patients with advanced cancer or other life-threatening or severely debilitating conditions associated with substantial unmet medical need.

FDA grants accelerated approval for Rybrevant Faspro in head and neck cancer

The FDA has granted accelerated approval to Janssen Biotech, Inc.’s Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed following platinum-based chemotherapy and immunotherapy. The decision was supported by clinical trial data showing an overall response rate of 42% among 102 patients, compared with response rates of approximately 20% or less associated with currently approved therapies. This marks the first drug approval in 10 years for this patient population following prior platinum-based chemotherapy. The approval is based on response rate and duration of response, with confirmatory studies required to verify clinical benefit.

FDA grants tentative approval for generic lenacapavir

The FDA has granted tentative approval to Dr Reddy’s Laboratories for the first generic version of lenacapavir, a long-acting injectable for HIV prevention developed by Gilead Sciences. The twice-yearly injection received tentative approval just 16 months after the originator product was approved. Its development was supported by Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute. The generic is intended for supply in 120 low- and middle-income countries covered by Gilead’s voluntary licensing agreement, with a proposed price of $40 per person annually. Initial supplies are expected before the end of 2026.