EMA use of patient disease registries for regulatory purposes

Methodological and operational considerations by a cross-committee task force on Registries

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. It has been published to seek comments and suggestions from all the interested parties. All the responses will be considered for the finalisation of the document with the EMA Committees in Q4 2019.

Please send your comments and suggestions before 30 June 2019 by sending the Form for submission of comments or an annotated version of the document (mentioning on the first page your name, affiliation and contact details) to: This email address is being protected from spambots. You need JavaScript enabled to view it.

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