Clinical efficacy and safety: clinical pharmacology and pharmacokinetics

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 completed public consultation

Finalised guidelines


Points to consider


Reflection papers

Question and answer (Q&A) documents

How useful was this page?

Add your rating