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Revision of the EMA “Guideline on the non-clinical requirements for radiopharmaceuticals”

messages in brief | 23/04/2019

The purpose of the ‚Draft guideline on the non-clinical requirements for radiopharmaceuticals‘ (EMA/CHMP/SWP/686140/2018) is to provide guidance on the required nonclinical data needed to support clinical development and marketing authorisation of radiopharmaceuticals.


Radiopharmaceuticals are a special, but clinically important group of medicinal products used for diagnostic or therapeutic purposes, frequently applied in the academic hospital setting.

 

The 2008 revision of a European guideline addressing the development of radiopharmaceuticals initially published in 1991 (3AQ20) exclusively focussed on manufacturing and quality aspects. With that, no dedicated guidance on the nonclinical requirements for these medicinal products was available anymore. The ICH guidelines ICH M3(R2), ICH S6(R1) and ICH S9 are in principle applicable, but partly exclude radiopharmaceuticals (e.g. ICH S9) – but in parallel some of the principles could be adapted.

 

The draft includes the different intended uses of radiopharmaceuticals including radiodiagnostics as well as radiotherapeutics. While the new guideline clarifies that the same principles of safety assessment apply as for other medicinal products it is also putting a focus on opportunities to targeted non-clinical programs according to specific development settings and product types: Regarding the non-radioactive part of radiopharmaceuticals, pharmacological, toxicological and/or clinical data are already frequently available. With that the general principles provided in ICH M3(R2) remain applicable without the need to conduct the entire non-clinical program. This should also assist to comply with the principles of 3Rs as well as with the European directive on the protection of animals used for scientific purposes.
The draft document is open for public consultation until 30 June 2019.

 

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