Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents

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

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

Please submit your comments to the following email address: radiopharmaceuticalsdg@ema.europa.eu.

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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