The HMA-EMA Catalogue of real-world data sources replaces the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Resources Database.
Data sources indexed in this catalogue are data sets sustained by a specified organisation, the data holder. The data source is characterised by the underlying population that can potentially contribute records to it, the trigger that leads to the creation of a record in the data source, and the data model used in the data source. The data holder can be any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as institutions, bodies, offices and agencies who have the right or obligation, in accordance with regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data.
This Catalogue describes real-world data sources through a set of collected metadata to aid anyone interested in using RWD to identify and use such data to investigate the use, safety, and effectiveness of medicines. The Catalogue of RWD sources serves as a hub for researchers, study sponsors and regulators seeking to identify data sets for conducting specific studies based on RWD in Europe or elsewhere.
Centres and networks that were previously indexed in the ENCePP Resource Database can continue to be registered under the 'Institutions' and 'Networks' sections of the catalogues.