Specifications for additional efficacy studies for medicines published in the Official Journal of the EU

News 11/04/2014

The European Commission has adopted a delegated act specifying the situations where a post-authorisation efficacy study can be required by medicines regulatory authorities. The act was published on 10 April 2014 in the Official Journal of the European Union (EU) and will enter into force on 30 April 2014.

Post-authorisation efficacy studies are conducted after a medicine has been granted a marketing authorisation. 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, however, the EU pharmacovigilance legislation that came into force in July 2012 has extended the legal framework in which they can be required.

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.

The European Medicines Agency, in collaboration with the EU Member States, is developing a scientific guidance document that will describe the design of post-authorisation efficacy studies.

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