Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021;49(3):456-485.
doi: 10.1017/jme.2021.67.

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

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

Alexander C Egilman et al. J Law Med Ethics. 2021.

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.

Keywords: Clinical Trials; Medical Product Regulation; Public Health; Regulatory Data; Transparency.

PubMed Disclaimer

Publication types

LinkOut - more resources