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 January 13, 2022

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


References