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 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

Registry Updates

• March 2023: Health Canada Registry Update - On February 23, 2023, Health Canada posted a draft guidance document for the protocol registration of clinical trials and public disclosure of results, proposed a public search portal. This document provides guidance to sponsors of Health Canada-authorized clinical trials to support the registration and public disclosure of results using international registries that complies with World … Continue reading "March 2023: Health Canada Registry Update"
• March 2023: CTIS Newsflash - On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
• March 2023: What’s New on ClinicalTrials.gov - On March 09, 2023, an update was posted on ClinicalTrials.gov, What’s New section, as follows: Virtual Webinar on ClinicalTrials.gov Modernization On April 25, 2023, from 12:30 to 3:00 pm Eastern Time, a webinar will take place providing an extensive update on the current Beta website and progress updates. Attendees will have the opportunity to hear … Continue reading "March 2023: What’s New on ClinicalTrials.gov"

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