The EU PAS register is a publicly available register of non-interventional post-authorization studies (PAS). All non-interventional post-authorization safety studies (PASS) relating to authorized medicinal products either imposed as an obligation by a competent authority are required to be registered. It is not a World Health Organization (WHO) recognized primary registry. It was established as per the EU pharmacovigilance legislation that requires the European Medicines Agency (EMA) to make public the protocols and abstracts of results of non-interventional post-authorization safety studies (PASS).
Registries at a Glance | |||||
Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
EU PAS | EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) | Post-authorization Safety Efficacy Studies |
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Registration and Results Requirements | |||
Registry | Activity | Legal Requirement | Timing |
EU PAS | Registration |
Yes |
Before the start of data collection |
Results |
Yes |
Within 12 months of the trial completion date |
Registry Updates
- June 2022: Key Performance Indicators to Monitor European Clinical Trial Environment - European Medicines Agency updated the page, Clinical Trials Regulation: progress on implementation by adding ‘Key performance indicators (KPIs) to monitor the European clinical trials environment (1 – 31 May 2022, edition 2)‘ document over the What’s New Section on June 27, 2022: KPIs to monitor the European clinical trials environment: It is the second report … Continue reading "June 2022: Key Performance Indicators to Monitor European Clinical Trial Environment"
- June 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions - European Medicines Agency updated about the upcoming events of Organisation Management System (OMS) Trouble Shooting Session for CTIS users to the What’s New Section on June 27, 2022: EMA will be hosting several OMS trouble shooting sessions on the following dates: July 21, 2022: 14.00 to 15.00 (CEST) September 22, 2022: 14.00 to 15.00 (CEST) … Continue reading "June 2022: CTIS Update for Organization Management System (OMS) Trouble Shooting Sessions"
- June 2022: CTIS Update - European Medicines Agency updated about the upcoming Clinical Trials Information System (CTIS) bitesize talks over the What’s New Section on June 27, 2022: EMA will host two bitesize talks, CTIS bitesize talks: Notifications – Part 1 and Notifications – Part 2 on September 28, 2022, and October 20, 2022, respectively. The sponsors will get an … Continue reading "June 2022: CTIS Update"
References
- EU PAS Register Guide. http://www.encepp.eu/encepp_studies/documents/EUPASRegisterGuide.pdf
- FAQ – EU PAS Register. http://www.encepp.eu/encepp_studies/documents/FAQ_EUPASRegister.pdf
- Guidance from EMA on the structure of protocol. https://www.ema.europa.eu/documents/other/guidance-format-content-protocol-non-interventional-post-authorisation-safety-studies_en.pdf
- Guidance from EMA on the structure of the abstract and final report. https://www.ema.europa.eu/documents/regulatory-procedural-guideline/guidance-format-content-final-study-report-non-interventional-post-authorisation-safety-studies_en.pdf