The 1,500th study was registered in the EU PAS (Post-Authorisation Studies) Register in April 20191. Following launch of the register in November 2010, it took over 2 years for the first 100 studies to be uploaded2, but it is now common for >200 studies to be registered each year3.

The register, which was launched by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the European Medicines Agency (EMA), provides a free, publicly accessible dedicated resource for the registration of post-authorisation studies on medicines.

In recent years, the requirement for a post-authorisation safety study (PASS) or drug utilisation study (DUS) following an MA has become increasingly common. A PASS4 is carried out to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures. A DUS describes how a medicinal product is prescribed and used in real-life clinical practice, and characterizes the population of patients who are prescribed the product.

For studies imposed as a condition of marketing authorisations (EU RMP category 1 and 2 studies), a synopsis must be submitted before the MA is granted, and a full protocol must be submitted shortly afterwards. As required by the 2010 Pharmacovigilance legislation, the protocols and abstracts of results of such studies need to be published, and the EU PAS register is the forum for this.

EUDRAC has written both the synopses and protocols for these studies for our clients. We have experience of the expected criteria and we also work with third-party providers who conduct the studies.

 

1http://www.encepp.eu/events/index.shtml

2https://www.ema.europa.eu/en/news/encepp-e-register-reaches-100-post-authorisation-studies

3https://www.ema.europa.eu/en/news/over-1000-studies-now-recorded-eu-register-post-authorisation-studies

4https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/post-authorisation-safety-studies-pass-0