Watch this space: launch of EMA-HMA catalogues of data sources and non-interventional studies in early 2024
date: 27/09/2023
These catalogues will:
- Help regulators, researchers and pharmaceutical companies identify studies and data sources suitable to address research questions, based on the so-called ‘FAIR’ (Findable, Accessible, Interoperable and Reusable) data principles;
- Support the assessment of study protocols and study results by providing quick access to information on the suitability of data source(s) proposed to be used in the study protocol or referred to in the study report; and
- Boost transparency of studies and data sources.
Improvements that the new catalogues will introduce include the use of an agreed set of metadata (data elements characterising both data sources and studies) and the link between a data source and study performed. Users will also benefit from a modern technology with enhanced view, search, export and data submission functionalities and will be required to register to submit and manage their content in the catalogues.
A series of activities to support the implementation of the new catalogues, including the registration process, are being planned and stakeholders will be contacted in the coming weeks.