Pink Sheet

EMA Outlines Regulatory Expectations On Use Of Patient Registries

13 Nov 2018

Building on its ongoing patient registry initiative, the European Medicines Agency has issued recommendations on the methodological and operational aspects of the use of patient disease registries and registry studies for regulatory purposes.

Index — Data From Patient Registries Can Support Regulatory Decision-Making • Source: Shutterstock

The European Medicines Agency is inviting stakeholder feedback on what might be considered good practice for collecting high quality data from patient disease registries, and the factors that should be considered for undertaking registry studies to support regulatory decision-making.

The EMA's proposals are outlined in a draft discussion paper that mainly focuses on patient disease registries, although many...