Normativa europea
Regulatory news
Launch of new HMA-EMA catalogues of real-world data sources and studies
![Immagine News](/media/cnyhiizm/cat-4.jpg?anchor=center&mode=crop&width=722&height=442)
EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues:
- The catalogue for RWD sources : enhances and replaces the ENCePP Resources Database (an EMA-coordinated index of resources of available research organisations, networks and data sources in the fields of pharmacoepidemiology and pharmacovigilance within Europe).
- The catalogue for RWD studies : expands and replaces the European Union electronic register of post-authorisationstudies (EU PAS Register).
Together, these Catalogues offer an improved and more efficient service for researchers, regulators, and pharmaceutical companies to:
- Facilitate the discoverability of adequate data sources to generate real-world evidence for regulatory purposes (e.g., identification of RWD data sources suitable for investigating a specific research question);
- Aid in the suitability assessment of data sources by providing clear and easy access to information from the study protocol and study report;
- Improve interoperability between studies and data sources;
- Improve transparency.
The catalogues are fully searchable and the data available in the registered entities can be exported.
Grazie per il tuo feedback!