News - January 10, 2019

EMA Public Consultation on Patient Registries

The European Medicines Agency (EMA) has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time.

Given the importance of registries in monitoring the safety of medicines as well as in supporting regulatory decision making, we would like to encourage you to send your comments by 14 January 2019 to in order to start developing a consolidated EUCOPE response.