New guidance for HMA-EMA Catalogues of real-world data sources and studies published

New guidance documents providing valuable insights on best practices for the users of the HMA-EMA Catalogues of real-world data sources and studies (RWD Catalogues) are published:

• Good practice guide provides regulators, researchers and other stakeholders with recommendations on effectively using the Catalogues to identify and assess the suitability of data sources for studies on the use, safety, and effectiveness of medicines. The guide underwent public consultation and has been adopted by the Methodology Working Party and the Committee for Medicinal Products for Human Use (CHMP).
• New user guide primarily aimed at users creating data records in the Catalogues, this guide includes detailed instructions on submitting and maintaining records, along with descriptions of the metadata fields.
• Updated list of metadata elements includes an improved description of data sources and study records based on users’ feedback. 

The RWD Catalogues, which were launched over a year ago, enhance transparency and access to real-world data for research and regulatory purposes. The Catalogues serve two key roles: 

• Open access resource: the Catalogues allow for the pre-registration of RWD studies in Europe and beyond, promoting transparency and reproducibility.
• Data sources hub: they act as a central resource for regulators, companies, and researchers to identify suitable data sources to investigate the use, safety, and effectiveness of medicines. 

Researchers can add information about their studies in the Catalogue of RWD studies. 

Data holders can add information about their data source in the Catalogue of RWD sources. 

More information: Real-world evidence | European Medicines Agency (EMA) | RWDCataloguesema [dot] europa [dot] eu (RWDcatalogues[at]ema[dot]europa[dot]eu)