News!
New functionalities released!
Record completeness score for data sources: A record completeness score has been introduced for data sources listed in the RWD Catalogue. This score reflects the extent to which the metadata fields for each record have been populated. This score is not related to the quality or completeness of the data source itself. Instead, it measures the completeness of the data source record within the RWD Catalogue and is calculated based on the percentage of key metadata fields that have been filled in. A higher percentage indicates a more complete record, while a lower percentage suggests that some information may be missing or incomplete.
- A similar record completeness score will soon be made available for study records as well.
Direct link between studies and EMA product page: Studies related to centrally authorised medicinal products are now directly linked to their corresponding EMA product page. Users can navigate from a study entry for a centrally authorised medicine to the relevant product page, where they will find consolidated product information, including authorisation details and assessment history.
Aim of the RWD Catalogues
The HMA-EMA Real-World Data (RWD) Catalogues provide a centralised and global repository of information on real-world data sources and studies. Their purpose is to enhance transparency in RWD research and support regulators, pharmaceutical companies and researchers in identifying and using real-world data to investigate the use, safety and effectiveness of medicines.
Catalogues of institutions and networks conducting RWD studies or holding RWD sources are also available. These complement the information on RWD sources and studies forming a comprehensive set of resources that aims to:
- Make RWD sources easier to find and compare by providing standardised, structured information that enables identification, characterisation and benchmarking of data sources;
- Improve transparency and reproducibility of RWD research through access to structured information (metadata) as well as protocols, study reports, and related resources - covering RWD studies conducted worldwide, whether regulatory-mandated or voluntary.
- Support interoperability between studies and data sources to facilitate study planning, data analysis and the evaluation of study protocols and results.
The catalogues offer a user-friendly environment that promotes information exchange, fosters collaboration and supports compliance with EU pharmacovigilance legislation through the registration of studies subject to regulatory requirements.
All Catalogues are interconnected, allowing seamless navigation between data sources, studies, institutions and networks. They are fully searchable and the data from registered entities can be easily exported for further use.
The Catalogues replaced the EU PAS Register and ENCePP Resources Database in 2024.
Important note for record owners
Records that were previously published in the ENCePP Resources Database or the EU PAS Register (data sources, networks, institutions, or studies) have been migrated to the RWD Catalogues. To claim a migrated record:
- Create an EU Login account if you do not have one by following these steps: EU LOGIN (europa.eu).
- Log into the RWD Catalogues using your EU Login account details. Logging into the RWD Catalogues for the first time is a necessary step to complete the record assignment process.
- Raise a ticket via EMA Service Desk (ServiceNow). You can find detailed information on how to raise a ticket on this page: Contact us | HMA-EMA Catalogues of real-world data sources and studies.