The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) aims to strengthen the monitoring of the benefit-risk balance of medicines, primarily by facilitating the conduct of high quality, multi-centre, independent post-authorisation studies (PAS) with a focus on observational research.
EMA set up the network in 2007. It consists of public institutions and contract and research organisations, working in collaboration with the European medicines regulatory network. Participation in ENCePP is voluntary.
Access the ENCePP website
ENCePP played a key role in developing the principles and best practices for the planning, design, conduct and reporting of post-authorisation safety studies (PASS). These are referenced in the good pharmacovigilance practices (GVP) guideline on PASS:
In February 2024, the EMA-HMA catalogues of real-world data replaced the European Union electronic register of post-authorisation studies (EU PAS Register) hosted on the ENCePP website.
The EU PAS Register contained public information on non-interventional post-authorisation studies (PAS).
The protocols and abstracts of results of imposed non-interventional PASS need to be published in the catalogue of studies mentioned above.
EMA coordinates ENCePP's activities and further development of the network. The ENCePP steering group oversees the implementation of the network's work plans.
EMA provides the ENCePP secretariat, which facilitates the work of the ENCePP steering group and supports the communication and information flow between ENCePP partners, stakeholders and any other interested party.
Collaboration of the network on specific objectives and activities is organised through working groups and special interest groups in line with EMA's multi-annual work programme.