EU’s Post-Authorization Study Register Reaches One Thousand Entries

Print 15 February 2017
BioPharm International

The European Union’s electronic Register of Post-Authorization Studies (EU PAS Register) has received its 1000^th upload, the European Medicines Agency (EMA) announced on Feb. 10, 2017. The open access platform, which was developed through the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, houses information on post-authorization research for drugs marketed in Europe. The information includes study protocols, study results, related publications, and more.

According to EMA, the EU PAS Register “reduces publication bias through increased transparency of medicines research, improves the quality of post-authorization studies by facilitating peer-review of protocols and results, facilitates collaboration among stakeholders, and ensures compliance with EU pharmacovigilance legislation requirements.” The studies in the register, which are mostly non-interventional, complement the evidence generated through the clinical development program supporting the initial marketing authorization of a drug. Valuable insight into the use of a drug in normal clinical practice is gained. This insight helps to fully characterize the safety and effectiveness of the drug once it is marketed and throughout its life span.

Companies are encouraged by EU regulators to register all non-interventional post-authorization studies, “regardless of who initiates, manages, or finances them. Companies must register all non-interventional post-authorization safety studies (PASS) imposed by regulators. They are encouraged to register PASS requested to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures.”

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