The European Medicines Agency (EMA) plans to release a draft guideline that will integrate Annex 1 into Part IV of the Guidelines on Good Manufacturing Practices (GMPs) specifically for advanced therapy medicinal products (ATMPs), as outlined in a new concept paper.
EMA said the current EudraLex Part IV for ATMPs does not align with the revised Annex 1, which incorporates a “more in-depth approach” to risk management as specified in the International Council on Harmonization (ICH) Q9 guidelines and ICH Q10 concepts describing a modern pharmaceutical quality system (PQS). Annex 1, which came into effect in August 2023, covers GMPs for sterile medicinal products…
