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 Oncology European Specialised Expert Community.

General guidelines

• Clinical evaluation of diagnostic agents
• Appendix 1 to the guideline on clinical evaluation of diagnostic agents on imaging agents

Guidelines on the product-specific core SmPC and product leaflet

• Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use
• Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator
• Core summary of product characteristics (SmPC) and package leaflet for (99Mo/99mTc) generator
• Core summary of product characteristics (SmPC) and package leaflet for fludeoxyglucose (18F)
• Core summary of product characteristics (SmPC) and package leaflet for fluorodopa (18F)
• Core summary of product characteristics and package leaflet for gadopentetate dimeglumine
• Core summary of product characteristics (SmPC) and package leaflet for gadoteric acid
• Core summary of product characteristics (SmPC) and package leaflet for iopamidol 300
• Core summary of product characteristics (SmPC) and package leaflet for iopamidol 370
• Core summary of product characteristics (SmPC) and package leaflet for nanocolloidal technetium (99mTc) albumin
• Core summary of product characteristics (SmPC) and package leaflet for sodium fluoride (18F)
• Core summary of product characteristics (SmPC) and package leaflet for radiopharmaceuticals
• Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) sestamibi
• Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) macrosalb

Concept papers

• Clinical evaluation of therapeutic radiopharmaceuticals in oncology
• Harmonisation and update of the clinical aspects in the authorised conditions of use for radiopharmaceuticals and other diagnostic medicinal products