Scientific guidance on post-authorisation efficacy studies - Scientific guideline

This guidance has been developed in accordance with Article 108a of Directive 2001/83/EC which provides a mandate for European Medicines Agency (EMA) in cooperation with competent authorities and other interested parties to draw up scientific guidance on PAES.

Keywords: Post-authorisation efficacy studies (PAES), efficacy, observational, randomised, trials pragmatic, explanatory, historical controls