European Union electronic Register of Post-Authorisation Studies (EU PAS)

European Union electronic Register of Post-Authorisation Studies (EU PAS)

European Union electronic Register of Post-Authorisation Studies (EU PAS)

Verified on September 9, 2021

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 English
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

  • September 2021: What’s New on ClinicalTrials.gov - Below update was posted on ClinicalTrials.gov What’s New section on September 16, 2021: Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated … Continue reading "September 2021: What’s New on ClinicalTrials.gov"
  • September 2021: UK Regulatory Update - Implementation of UK HRA’s New Reporting Standards for Clinical Research As per the latest update from UK Health Research Authority, new reporting standards have been implemented to ensure that all researchers fulfill their responsibilities to make their research open and transparent. This is in line with the commitments set out in the Make it Public research … Continue reading "September 2021: UK Regulatory Update"
  • September 2021: Peru Update - A notification (PRESS RELEASE No. 005-2021-OGITT/INS) dated September 09, 2021, was published on the Peruvian Registry of Clinical Trials (REPEC) website on September 13, 2021. In context of the same: Due to preventive maintenance, services of the REPEC Version 2 System will be temporarily suspended as of Sunday, September 12, 2021. The services provided in … Continue reading "September 2021: Peru Update"

References