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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article25 April 2019European Medicines Agency

EU PAS Register: 1,500 studies registered in April 2019

The 1,500th study was registered in the EU PAS Register (study EUPAS29415) in April 2019. This study, titled 'Observational Patient Evidence for Regulatory Approval and uNderstanding Disease' (OPERAND), looks at the replicability of two RCTs with observational data and is conducted in the US by Harvard Pilgrim Health Care Institute, illustrating the increasing globalisation of the EU PAS Register. The register is key to supporting transparency in post-authorisation research: by April 2019, 46% of the registered studies were requested by regulators, 10% were imposed as a condition of marketing authorisations (i.e. EU RMP category 1 and 2 studies) and 84% of those eligible had their protocol and abstract of results posted in the EU PAS Register. By facilitating the review of protocols and results, the EU PAS Register is also increasingly used for academic research.

 

Related information:

» EU PAS Register

Details

Publication date
25 April 2019
Author
European Medicines Agency