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Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration. | LitMetric
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Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.

Alexander C Egilman Amy Kapczynski Margaret E McCarthy Anita T Luxkaranayagam Christopher J Morten Matthew Herder Joshua D Wallach Joseph S Ross

J Law Med Ethics

Published: November 2021

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

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 Source
http://dx.doi.org/10.1017/jme.2021.67DOI Listing

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