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||
|Registration and Results Requirements|
|Before the start of data collection|
|Within 12 months of the trial completion date|
- Approvals Of Medicines from Regulatory Agencies Despite Omitted Clinical Trials - As per a post dated 3rd January, 2022 on TranspariMED, a drug to treat attention deficit hyperactivity disorder (ADHD) was approved by several regulatory agencies without all relevant clinical trials having been reviewed, a study published in November 2021 suggests. The omitted trials accounted for a median of 45% of all data from participants in relevant … Continue reading "Approvals Of Medicines from Regulatory Agencies Despite Omitted Clinical Trials"
- December 2021: Netherlands Update - New online tool provides insight into the scope of CTR The CCMO on December 23, 2021, has released an update to provide information about the Clinical Trial Decision Tool which was jointly developed by the Paul Janssen Futurelab and the CCMO. The new Clinical Trial Decision Tool helps determine whether the drug research falls within the … Continue reading "December 2021: Netherlands Update"
- December 2021: Webinars for Transitioning to Combined Review - The HRA UK on December 22, 2021, has released an update for the Combined Review process. They will be running a series of free, live webinars during December and January to provide an overview of upcoming changes and how they can affect individually the CTIMP applicants, sponsors, and NHS/HSC organizations depending on the role. Bookings … Continue reading "December 2021: Webinars for Transitioning to Combined Review"