Non-clinical requirements for radiopharmaceuticals - Scientific guideline

This new guideline is intended to provide guidance on the required non-clinical data to support clinical development and approval of radiopharmaceuticals. The document is intended to complement currently available guidelines (such as ICH M3(R2), ICH S6(R1), ICH S9 or the EMA guideline on "strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products" and includes the different intended uses of radiopharmaceuticals including radiodiagnostics as well as radiotherapeutics. The new guideline is focusing on opportunities to targeted non-clinical programs according to specific development settings and product types and is not intended to duplicate guidance related to dosimetry.

Keywords: Radiopharmaceuticals, radiodiagnostics, radiotherapeutics, non-clinical safety assessment

Current version

Draft guideline on the non-clinical requirements for radiopharmaceuticals - First version

Draft: consultation closedConsultation dates: 22/11/2018 to 30/06/2019Reference Number: EMA/CHMP/SWP/686140/2018

Document history

Draft guideline on the non-clinical requirements for radiopharmaceuticals - First version

Draft: consultation closedConsultation dates: 22/11/2018 to 30/06/2019Reference Number: EMA/CHMP/SWP/686140/2018

Concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals - First version

Draft: consultation closedConsultation dates: 01/08/2017 to 31/10/2017Reference Number: EMA/CHMP/SWP/545959/2016Summary:

This concept paper is intended to seek external stakeholder views on potential guidance development related to overarching considerations for non-clinical data in support of clinical development and approval of radiopharmaceuticals. This guidance is intended to complement currently available guidelines (such as ICH M3(R2), ICH S6(R1), ICH S9 or the EMA Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products) and includes the different intended uses of radiopharmaceuticals including radiodiagnostics as well as radiotherapeutics. The paper will focus on opportunities to targeted non-clinical programs according to specific development settings and product types and is not intended to duplicate guidance related to dosimetry.