Clinical efficacy and safety: clinical pharmacology and pharmacokinetics

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The European Medicines Agency’s scientific guidelines on clinical pharmacology and pharmacokinetics help medicine developers prepare marketing authorisation applications for human medicines.

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

Draft guidelines under public consultation


Finalised guidelines 

Points to consider

Reflection papers

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Questions about clinical pharmacology, activities of the PKWP and other general enquiries: Send a question to the European Medicines Agency.

Comments on guidelines under public consultation: Please complete the form for submission of comments on scientific guidelines and email it to