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.
Health Law and Policy | Law | Medical Jurisprudence
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Alexander C. Egilman, Amy Kapczynski, Margaret E. McCarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach & Joseph S. Ross,
Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration,
J. L. Med. & Ethics
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