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September 24, 2020

European Medicines Agency Seeks Public Comments on Draft Guideline on Registry-Based Studies

September 24, 2020—The European Medicines Agency (EMA) announced the publication of its draft Guideline on Registry-Based Studies for a 3-month public consultation period. Stakeholders are invited to send their comments via an online form by December 31, 2020. After the public consultation, comments from stakeholders will be analyzed and considered in the final document that will be published in 2021.

As part of the consultation process, EMA is hosting a virtual workshop on October 19 to present the draft guideline to key stakeholders. The workshop provides an opportunity to discuss questions, perspectives on the usefulness of the document, and recent experience on methodologic aspects of registry-based studies. 

According to EMA, the new draft guideline aims to optimize the use of registry-based studies as a source of real-world evidence. It addresses methodologic, legal, and operational aspects in the use of registry-based studies to support regulatory decision-making.

The guideline focuses on studies based on disease registries or condition registries (ie, registries characterized by the presence or occurrence of a particular disease, disease-related patient characteristic, or a specific condition) to examine the use, safety, and effectiveness of medicines prescribed to or consumed by patients included in the registry. It also outlines key regulatory considerations related to the establishment and management of patient registries, which are important for their use in registry-based studies.

EMA advised that the draft guideline was developed by the EMA Cross-Committee Task Force on Registries in consultation with the European Medicines Regulatory Network. The document incorporates feedback received on a discussion paper on methodologic and operational considerations in the use of patient disease registries for regulatory purposes and insights gained during five multi-stakeholder workshops on disease-specific registries.

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