European Commission specifies post-authorization efficacy study guidelines

The European Commission has adopted a delegated act specifying the situations where a post-authorization efficacy study can be required by medicines regulatory authorities. The act was published yesterday in the Official Journal of the European Union and will enter into force on April 30.

The aim is to enable regulators to request such studies when there are important questions about the efficacy of the medicine that can only be answered once the product is in general use, or when questions arise in the post-authorisation period.

Post-authorization efficacy studies are conducted after a medicine has been granted a marketing authorization. They aim to address concerns related to the efficacy of a medicine in certain situations, such as everyday medical practice, in specific populations, or over time. This type of study already existed but the EU pharmacovigilance legislation that came into force in July 2012 has extended the legal framework in which they can be required.