Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents

The European Medicines Agency's scientific guidelines on radiopharmaceuticals and diagnostic agents help medicine developers prepare marketing authorisation applications for human medicines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

More information is available on the activities of the CHMP's Radiopharmaceuticals Drafting Group.

General guidelines

Guidelines on the product-specific core SmPC and product leaflet

Concept papers


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