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

Authors

Alexander C. Egilman, Yale Law School
Amy Kapczynski, Yale Law SchoolFollow
Margaret E. McCarthy, Brooklyn Defender Services
Anita T. Luxkaranayagam, University of Connecticut School of Medicine
Christopher J. Morten, Columbia Law SchoolFollow
Matthew Herder, Dalhousie University
Joshua D. Wallach, Yale School of Public Health
Joseph S. Ross, Yale School of Medicine

Document Type

Article

Publication Date

2021

DOI

https://doi.org/10.1017/jme.2021.67

Abstract

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.

Disciplines

Health Law and Policy | Law | Medical Jurisprudence

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Recommended Citation

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, 49 J. L. Med. & Ethics 456 (2021).
Available at: https://scholarship.law.columbia.edu/faculty_scholarship/3315