The European Medicine Agency (EMA) has issued the guideline on the non-clinical requirements for the radiopharmaceuticals. The document provides details regarding the data that must be submitted for the non-radioactive part of the radiopharmaceuticals. The guideline focuses on the non-clinical testing requirements for radiopharmaceuticals and is available for consultation and open for comments until June 30, 2019.
If you are interested in taking a look on the European regulatory framework, the document is accessible if you follow the link below.
https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-non-clinical-requirements-radiopharmaceuticals-first-version_en.pdf
