In May 2022, the HMA-EMA Big Data Steering group published the first version of a list of metadata elements describing real-world data sources and studies to help pharmaceutical companies and researchers to identify and use such data when investigating the use, safety and effectiveness of medicines.
The European medicines regulatory network is working to develop a new electronic public catalogue of data sources and studies based on the above-mentioned list of metadata. This new catalogue will replace and enhance the current ENCePP Resources Database and the EU PAS Register, improving this way data discoverability by means of providing improved catalogue search features on a wider set of metadata. The new catalogue will facilitate researchers in discovering the most suitable data sources for their studies and it will support the assessment of study protocols and study results. Also, it aims at providing higher interoperability between studies and data sources.
The new catalogues and metadata list represent the implementations of one of the ten priority recommendations set by the joint the HMA-EMA Big Data Task Force in 2020, which is “Data discoverability”. This priority is being accomplished by a set of relevant deliverables outlined in the revised Big Data Steering Group workplan 2022-2025.
In this context, the EMA is planning to migrate the resources indexed in the ENCePP Resources Database and the EU PAS Register to the new catalogue. The Agency has sent dedicated emails to the contact points of the data sources already included in the ENCePP Resource Database in order to get support for the update and completion of the records in accordance with the new metadata list, that will feed into the new catalogues.
Related information: Big data | European Medicines Agency (europa.eu)
Details
- Publication date
- 28 February 2023
- Author
- European Medicines Agency