Clinical efficacy and safety: clinical pharmacology and pharmacokinetics

  • Email
  • Help

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

For the specific questions on the pharmacokinetic evaluations addressed to the Pharmacokinetic Working Party, see:

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

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

How useful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings