EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals
The EMA has published a concept paper outlining a future revision of Annex 3 (Manufacture of Radiopharmaceuticals) of the EU GMP Guidelines. The paper was developed in collaboration with PIC/S and adopted by the GMDP Inspectors Working Group (IWG) at its November meeting.
The proposed revision aims to address areas not covered in the current version of Annex 3 (issued in 2008), clarify existing requirements, and support innovative manufacturing and control approaches for radiopharmaceuticals. The updated guidance is intended to be applicable across the EU/EEA and PIC/S participating authorities.
The public consultation is open until 15 February 2026.
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