EMA To Improve Dialogue With Registry Holders To Support Drug Evaluation
Executive Summary
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.
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EMA explores making better use of patient registries to support drug evaluation
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.