Guidance related to Radiopharmaceuticals

EU Guidance.

EU - Guideline on Radiopharmaceutcials

Concept paper on the revision of the Guideline on Radiopharmaceuticals - Revision 1

Eudralex - Volume 4 Good manufacturing practice (GMP) Guidelines, Annex 3: Manufacture of Radiopharmaceuticals

EDQM - Guide for the elaboration of monographs on radiopharmaceutical preparations, (2018)

EANM guideline on the validation of analytical methods for radiopharmaceuticals

Draft - Guideline on the non-clinical requirements for radiopharmaceuticals

PIC/S

Guide to Good Manufacturing Practice for Medicinal Products - Annexes - Specifically Annex 3 - Manufacture of radiopharmaceuticals

PIC/S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS - Specifically Annex 3 - Good practices for the preparation of radiopharmaceuticals in healthcare establishments

WHO / IAEA

International Atomic Energy Agency and World Health Organization guideline on good manufacturing practices for radiopharmaceutical products

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