EMA Proposes Updates to GMP Guidelines for Advanced Therapy Medicinal Products

On May 8, 2025, the European Medicines Agency (EMA) published a concept paper proposing revisions to Part IV of the EU GMP Guidelines, focused on Advanced Therapy Medicinal Products (ATMPs). Key updates include alignment with the revised Annex 1 (effective August 2023), incorporating ICH Q9 and Q10 principles for quality risk management and pharmaceutical quality systems, and addressing new manufacturing technologies like automated and closed single-use systems.

The revisions also clarify cleanroom classifications and barrier system use, including isolators and Restricted Access Barrier Systems (RABS), while retaining biosafety cabinet provisions for manual manipulations. Legal references and definitions are updated to reflect new regulations on human-origin substances.

The current guidelines date from November 2017. The public consultation is open until July 8, 2025, with feedback welcomed via the EMA’s EU Survey tool. Full details are available on the EMA website.

25-05-2025