Platform for post-authorisation studies registered as EU trade mark
'EU PAS Register' includes more than 1,100 observational post-authorisation studies
The European Union Intellectual Property Office (EUIPO) has approved the registration of 'EU PAS Register' as a European Union trade mark (EUTM). A EUTM grants exclusive rights in all current and future Member States of the European Union (EU), and can be renewed every 10 years.
Launched in November 2010, the EU PAS Register is a unique source of information on the safety and effectiveness of authorised medicines. It is an openly accessible platform with information on observational1 post-authorisation research in medicines already marketed in Europe and includes study protocols, study results, related publications and other relevant information.
The information in the EU PAS Register helps to reduce publication bias through increased transparency of medicines research, improves the quality of post-authorisation studies by facilitating peer-review of protocols and results, promotes collaboration among stakeholders, and ensures compliance with EU pharmacovigilance legislation requirements.
By 31st July 2017, 1,145 studies had been registered on the platform. 583 (50.9%) have been requested by a regulatory authority and 368 (32.1%) are finalised.
The trade mark, registered on 10 July 2017, will reinforce the European Medicines Agency's (EMA) legal control over the name of the platform and its content. The EU PAS Register is now acknowledged internationally as a repository of observational post-authorisation studies. The use of the platform is widely recommended in scientific publications, guidelines and textbooks. Although initially the main aim of the EU PAS Register was to collect studies conducted in the European Union, researchers from outside the EU are also registering studies to increase transparency of their research.
The EU PAS Register was developed through the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by EMA to support research in pharmacoepidemiology and pharmacovigilance.
- 1 In observational or non-interventional research the assignment of the patient to a therapeutic strategy is not decided in advance by a trial protocol but falls within current medical practice, and the prescription of the medicine is clearly separated from the decision to include the patient in the study.