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
- Clinical evaluation of diagnostic agents - Scientific guideline
- Appendix 1 to the guideline on clinical evaluation of diagnostic agents on imaging agents - Scientific guideline
Guidelines on the product-specific core SmPC and product leaflet
- Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use - Scientific guideline
- Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for (99Mo/99mTc) generator - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for fludeoxyglucose (18F) - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for fluorodopa (18F) - Scientific guideline
- Core summary of product characteristics and package leaflet for gadopentetate dimeglumine - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for gadoteric acid - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for iopamidol 300 - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for iopamidol 370 - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for nanocolloidal technetium (99mTc) albumin - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for sodium fluoride (18F) - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for radiopharmaceuticals - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) sestamibi - Scientific guideline
- Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) macrosalb - Scientific guideline
Concept papers