Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
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