EMA: Concept Paper on the Revision of GMP Guide Part IV on ATMPs
EMA has published a concept paper on the revision of GMP Guide Part IV on ATMPs for public consultation.
The proposed revision will embrace the use of new technologies that are not currently covered in the current version (e.g. automated advanced technology, (closed) single use systems, fast rapid microbiological testing methods).
Following the publication of a new regulation on standards of quality and safety for substances of human origin intended for human application there is also a need to update legal references and definitions for the starting material of human origin.
Since the introduction of the revised GMP Annex I for the manufacture of sterile products has modified and clarified some requirements compared to the current ATMP guideline, the proposed revision of the ATMP guideline is to align with the current Annex 1 while maintaining a flexible approach for the production of ATMPs.
It is noted that the current revision will only focus on the sterile manufacture sections related to the updated version of the Annex 1 and not to update any other topics/sections outside of that scope.
The consultation closes on 8 July 2025.
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