Launch of the HMA-EMA real-world data (RWD) catalogues and the new ENCePP website

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have launched the electronic Catalogues of RWD sources and studies, replacing the former ENCePP Resource Database and EU PAS Register. The catalogues are moving away from the supervision of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and can be accessed via the EMA website.

The catalogues will help medicines regulators, researchers and pharmaceutical companies to identify the most suitable data sources to address specific research questions and support the assessment of study protocols and results. The aim is to promote transparency, encourage the use of good practices, and build trust in research based on RWD.

Institutions and networks that wish to join ENCePP need to register in the new catalogues, and tick ‘yes’ to the ENCePP partner question. Studies previously published in the EU PAS Register can be updated by the study owner directly in the Catalogue of RWD studies. New studies should also be registered in the Catalogue of RWD studies, including protocols and abstracts/reports of results of non-interventional post-authorisation safety studies (PASS) imposed as an obligation of marketing authorisation by a competent authority.

The migrated studies, data sources, centres/institutions and networks are not automatically allocated to the initial record owners. To access these records in the HMA-EMA Catalogues, initial lead investigators/administrative contacts must create an EU Login account: EU LOGIN (europa.eu). To ensure that the records are assigned to the individual EU Login account, the lead investigators/administrative contacts must identify all their records by filling the following form: https://ec.europa.eu/eusurvey/runner/EMA-HMA_Catalogues.

All queries related to the new catalogues should be submitted via https://catalogues.ema.europa.eu/contact-us. Due to the migration from the ENCePP website, the former EU PAS Register email address (eu_pas_registerema [dot] europa [dot] eu (eu_pas_register[at]ema[dot]europa[dot]eu)) is no longer available.

To reflect these changes, a refreshed ENCePP website has also been launched with a new design and new ENCePP logo. While the EU PAS Register and the ENCePP Resource Database have moved from the ENCePP website, all other key tools of the ENCePP network, including the ENCePP Guide on Methodological Standards in Pharmacoepidemiology and the ENCePP Code of Conduct, have been maintained on the new ENCePP website. The ENCePP website now also benefits from an enhanced search feature and a more user-friendly structure. The website is available at a new URL: https://encepp.europa.eu.

Related information:

RWD Catalogues

RWD Catalogues helpdesk

Big data on the EMA website

GVP Module VIII – Post-authorisation safety studies