Position paper to facilitate patient access to radiopharmaceuticals: considerations for a suitable pharmaceutical regulatory framework

Korde, Aruna; Patt, Marianne; Selivanova, Svetlana V.; Scott, Andrew M.; Hesselmann, Rolf; Kiss, Oliver; Ramamoorthy, Natesan; Todde, Sergio; Rubow, Sietske M.; Gwaza, Luther; Lyashchenko, Serge; Andersson, Jan; Hockley, Brian; Kaslival, Ravindra; Decristoforo, Clemens

doi:10.1186/s41181-023-00230-2

EJNMMI Radiopharmacy and Chemistry

Table 3 Relevant guidelines and texts in relation to GMP for radiopharmaceuticals

From: Position paper to facilitate patient access to radiopharmaceuticals: considerations for a suitable pharmaceutical regulatory framework

Guideline/Text	Origin/ Organisation	Topic	References
General GMP guidelines
PE 009-17 Guide to Good Manufacturing Practice for Medicinal Products Part I and Annexes (including Annex 3 on “Manufacturing of radiopharmaceuticals”)	PIC/S	General GMP guidelines	PIC/S (2023a, b)
WHO Good Manufacturing Practices	WHO	General GMP guidelines	World Health Organization (2014, 2010)
Current Good Manufacturing Practice (cGMP) Regulations	FDA	Official US GMP guidelines	U.S. Food & Drug Administraion (2023)
Volume 4 of "The rules governing medicinal products in the European Union": Good Manufacturing Practice (GMP) guidelines (including Annex 3 on “Manufacturing of radiopharmaceuticals”)	EU	Official EU GMP guidelines	European Commission (2017)
Specific GMP guidelines for radiopharmaceuticals
International Atomic Energy Agency and World Health Organization: guideline on good manufacturing practices for radiopharmaceutical products	IAEA/WHO	General GMP guidelines on RP preparation	World Health Organization (2020)
PET Drugs – Current Good Manufacturing Practice	FDA	GMP specific for PET RP manufacturers	FDA (2018)
PE010-4. Good practices for the preparation of medicinal products in healthcare establishments	PIC/S	GMP recommendations for pharmaceuticals (including RPs) prepared in hospitals	PIC/S (2014)
Guidelines on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals	EANM	cGRPP for the small scale preparation of RPs	Gillings et al. (2021)
IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products	IAEA/WHO	GMP for investigational RPs	World Health Organization (2022)
IAEA/WHO guideline on good manufacturing practices for in-house cold kits for radiopharmaceutical preparations	IAEA/WHO	GMP for in-house prepared cold kits for RP preparations	In progress
Other documents
EANM guidelines for the preparation of an investigational medicinal product dossier (IMPD)	EANM	Guideline for the preparation of an IMPD, including practical examples	Todde et al. (2014)
Guidelines on Radiopharmaceuticals	EMA	EU guidelines for MA applicant	EMA. European Medicines Agency (2018)
Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients	Council of Europe	Requirements for the preparation of medicinal products in pharmacies	Scheepers et al. (2017)

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