EMA explores making better use of patient registries to support drug evaluation
This article was originally published in SRA
The European Medicines Agency is looking at ways to make better use of existing patient registries - and help set-up new ones where needed - to generate additional data for the benefit-risk evaluation of medicines1. The project involves exploring, among other things, whether a registry can be used simultaneously to support both regulatory and health technology assessments.
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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.
The European Medicines Agency is looking at ways to promote the systematic use of patient registries to support the evaluation of the benefits and risks of medicines.