Migration of the EU PAS Register and ENCePP Resource Database and launch of the new ENCePP website in early 2024

The European Medicines Regulatory Network (EMRN) is developing new public electronic catalogues for data sources, studies, institutions and networks. The new catalogues will replace and enhance the current ENCePP Resources Database and the EU PAS Register, and aim to:

• Facilitate the discoverability of data sources to generate adequate evidence for regulatory purpose, i.e., the initial identification of data sources suitable to investigate a specific research question;
• 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;
• Improve interoperability between studies and data sources;
• Improve transparency.

Ahead of the planned launch in early 2024, EMA is working on migrating studies, data sources, centres and networks from the ENCePP website to the new EMA-HMA Catalogues on the EMA website.

Studies, centres, networks

The below actions are required from the principal lead investigator (PLI) of studies indexed in the EU PAS Register and the Administrative contacts of the centres and networks:

 

1. To access the records after go-live of the EMA-HMA Catalogues, the PLI/Administrative contact needs to create an EU Login account: EU LOGIN (europa.eu).
2. To ensure that the records are assigned to the individual EU Login account, the PLI/ Administrative contact needs to identify all their records by filling a form: https://ec.europa.eu/eusurvey/runner/EMA-HMA_Catalogues. Records that are registered in the EU PAS Register/ENCePP Resource Database with a generic organisation email address, must be changed to individual accounts. The use of a generic email/mailbox for registrations will no longer be possible, due to the improved secure EU login features (e.g. double authentication process).
3. Draft entries in the current EU PAS Register will not be migrated to the new EMA-HMA Catalogue of studies. Draft entries should be submitted for publication before 1 January 2024 to ensure migration to the new catalogues.
4. In the new EMA-HMA Catalogue of non-interventional studies, all newly submitted protocols will automatically be published. The option of hiding a protocol before finalisation of the study will no longer be possible. The currently “hidden” protocols of studies in the EU PAS Register will not be automatically migrated. PLIs who wish to migrate and publish their (now hidden) study protocol, will need to update Question 17 – Full protocol in the EU PAS Register before 1 January 2024 by ticking ‘Yes’. Any remaining protocols that are hidden in the EU PAS Register will need to be re-uploaded by the study owner after the launch.

Data sources

Administrative contact points of data sources in the ENCePP Resource Database have been previously contacted to confirm their interest regarding the migration of the data sources to the new Catalogue of data sources. Further communication will be provided via email to those who have confirmed interest.

Data sources who have not confirmed interest in being migrated to the new Catalogue still have the opportunity and are strongly encouraged to enter their data once the new Catalogue is live in early 2024, after creating an EU login account: EU LOGIN (europa.eu).

Downtime and new ENCePP website

The expected downtime of the EU PAS Register and the ENCePP Resource Database will be in January 2024. Precise date and updates on the migration will be posted on the current ENCePP website. New submissions and updates will not be possible during this downtime. The ENCePP website, EU PAS Register, and ENCePP Resource Database will remain available for viewing and searching.

On the day of the launch of the new catalogues, the new ENCePP website will be also launched at www.encepp.europa.eu, reflecting the changes and the migration of the databases from the current website. Visitors will be automatically redirected from the current URL, www.encepp.eu, to the new one. Most content (apart from the databases) will be migrated to the new website, including old news items, Plenary meeting reports and the ENCePP Guide on Methodological Standards in Pharmacoepidemiology. Some of the many improved features of the new website will include more user-friendly navigation and search.

For questions related to the migration of the EU PAS Register and ENCePP Resource Database, and for further information on the new catalogues, please contact: metadataema [dot] europa [dot] eu (metadata[at]ema[dot]europa[dot]eu).
For questions on the new ENCePP website, please contact: encepp_secretariatema [dot] europa [dot] eu (encepp_secretariat[at]ema[dot]europa[dot]eu).

Upcoming event where the new EMA-HMA catalogues will be presented:

• 19 December 2023: Quarterly system demo – Q4 2023 | European Medicines Agency (europa.eu), agenda item 6. ‘Real World Metadata Catalogues (RWMC)’

Related information:

• Metadata list describing real world data: Metadata are descriptive data that characterise other data to create a clearer understanding of their meaning and achieve greater reliability and quality of information.
• Draft good practice guide for the use of the metadata catalogue of real-world data sources: The draft guide provides recommendations on how to use the catalogues in order to identify suitable real-world data sources for studies, including use cases, and describes the metadata elements that are envisaged to be collected to address a specific research question.
• EU Real World metadata list, good practice guide and catalogues of data sources and studies: Presentation from the EMA/HMA Big Data Stakeholder Forum 2022.