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.


Posted on the EMA website on 1 August 2017