EMA released the guideline on the non-clinical requirements for radiopharmaceuticals
Posted: April 6, 2019

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.


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