The European Medicines Agency (EMA) has just announced that European Union (EU) register for post-authorisation studies (PAS) has just uploaded its 1000th study. The EU PAS Register is a publicly open domain which promotes the exchange of information between regulatory bodies, academia and sponsors. It contains information on studies conducted on medicines already approved for marketing authorisation and focuses more on non-interventional studies.
The purpose of the EU PAS Register is to:
- develop transparency,
- diminish publication bias,
- encourage exchange of information and aid collaboration
- guarantee compliance with EU pharmacovigilance legislation.
The studies allow for an increased insight for the use of the medicine in normal clinical practice and provide essential safety and effectiveness profiles throughout the life span of the medicine. It can also offer supplementary evidence to support the initial marketing authorisation decision.
Registration of non-interventional post-authorisation studies is encouraged by EU regulators. Companies are to register non-interventional post-authorisation safety studies (PASS) when requested so that they can access information on a medicines safety or see how effective its risk-management measures are. Post-authorisation efficacy studies (PAES) not in clinical trials are also encouraged to be entered into the EU PAS Register.
For more information on this please visit the EMA website here.
To visit or submit a study onto the register please visit here.