EMA Consultation: Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations
The European Medicines Agency has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations.
This discussion paper has been prepared by the Cross-Committee Task Force on Registries established by the EMA Patient Registries Initiative. The main objective of this initiative is to facilitate use of patient registries to support regulatory decision-making.
The paper discusses methodological and operational aspects of the use of patient disease registries and registry studies for regulatory purposes.
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. Patient registries can play an important role in monitoring the safety of medicines.
The discussion paper is available by clicking here.
Comments should be provided either using this template or by simply annotating the document (mentioning on the first page your name, affiliation and contact details) and sent to EMAregistries@ema.europa.eu by 30 June 2019.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).