Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals

24th December 2025

Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals 

Summary (focused on the updates / what’s changing):
EMA (via the GMP/GDP Inspectors Working Group) proposes updating Annex 3: Manufacture of Radiopharmaceuticals, last issued in 2008, because multiple revisions to GMP, ICH guidance and EU legislation have introduced new concepts that are not covered in the current annex. The revision is intended to:

• Bring Annex 3 up to date with modern manufacturing and quality expectations for radiopharmaceuticals, including newer approaches to risk management and quality systems. 

• Clarify ambiguous sections where inspection experience has shown inconsistent interpretation across sites and inspectors. 

• Align EU and PIC/S expectations, ensuring the annex is applicable across the EU/EEA and PIC/S participating authorities (i.e., harmonised global inspection expectations). 

• Better reflect current radiopharmaceutical practice, including how products are manufactured and controlled today (notably short shelf-life products, small batch sizes, and specialised facilities). 

The concept paper sets the direction and rationale for the revision, and signals that a revised Annex 3 will be developed to reduce uncertainty and improve consistency across GMP inspections in this sector. 

Link: Concept paper on the revision of Annex 3 of the GMP guidelines for radiopharmaceuticals

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