EMA Touts Growth of Post-Authorisation Study Database

Regulatory NewsRegulatory News | 13 February 2017 |  By 

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database.

The database, referred to as the EU PAS Register (European Union electronic register of post-authorisation studies), is operated by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), and was established with the aim of increasing transparency for post-authorisation studies.

The EU Pass Register is also used to host post-authorization safety studies imposed on drugmakers by EMA as part of their postmarketing requirements.

"The information in the EU PAS Register reduces publication bias through increased transparency of medicines research, improves the quality of post-authorisation studies by facilitating peer-review of protocols and results, facilitates collaboration among stakeholders, and ensures compliance with EU pharmacovigilance legislation requirements," EMA writes.

Over the last several years, the number of studies available in the EU PAS Register has grown dramatically: from fewer than 100 in 2012, to 571 in 2014, to 1,282 in 2016.

Going forward, ENCePP says its goal for the EP PAS Register will be to continue increasing the number of studies registered, and in collaboration with EMA, "increase routine surveillance of registrations and compliance follow-up" for imposed studies.


ENCePP Work Plan


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