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Regulatory News
May 9, 2025
by Joanne S. Eglovitch

EMA proposes to incorporate Annex 1 in GMP guide for ATMPs

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.
 
EMA said that “since the release of the revised Annex 1, the incorporation of relevant ICH concepts (such as Quality Risk Management [QRM] and Pharmaceutical Quality System [PQS]), the introduction of Contamination Control Strategy (CCS), and recent technological advancements are not yet reflected in the current ATMP GMP guideline.”
 
The agency added that “the rationale was to allow academia, developers and manufacturers to achieve the consistent production of high-quality ATMPs across the European Union.”
 
In addition, the current ATMP guideline does not reflect new technologies in the manufacture of ATMPs, such as the use of isolators and restricted access barrier systems (RABS) to prevent product contamination.
 
The deadline for commenting is 8 July, and EMA plans to issue a draft guideline in September 2026. Plans are to have a guideline ready for adoption in May 2027. Comments should be submitted here.
 
EMA
 

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