Guideline on registry-based studies

The EMA Patient Registry Initiative and the Cross-Committee Task Force on Registries have explored ways to improve the use of patient registries in the context of benefit-risk evaluation of medicinal products

The guideline was developed based on the comments received on the discussion paper on ‘Methodological and operational considerations on the use of patient disease registries for regulatory purposes’, that went through a public consultation between November 2018 and June 2019, and a consultation of EMA Committees and Working parties. It focuses on studies using disease registries as a data source, and primarily targets marketing authorisation applicants and holders. It is also relevant to patients and to persons involved in the funding, creation and management of registries, those participating in the collection and analysis of registry data, and those planning to use the registry information and infrastructure to perform registry-based studies with a possible regulatory purpose. An annex provides considerations on good practice for registries to increase their usefulness for regulatory purpose.

Keywords: Registries, registry, patient registry


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