EMA – Public consultation: Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
This concept paper proposes to update Annex 3, Manufacture of Radiopharmaceuticals, of the Good Manufacturing Practice (GMP) guide. Annex 3 is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the Participating Authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The current version was issued in 2008. The aim of this revision is to provide guidance within some areas that were not covered in the current version, clarify some sections, and support innovative pharmaceutical manufacturing and control6 approaches, as better detailed in the following paragraph 3 “Discussion”.
The Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals is open to consultation until 15 February 2026.
Templates and other open consultations can be found on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (18 février 2026). EMA – Public consultation: Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals. ELSIBI. Consulté le 7 octobre 2026 à l’adresse https://doi.org/10.58079/15pw0
