Document Type
Article
Publication Date
2021
Keywords
Transparency, Clinical Trials, Regulatory Data, Medical Product Regulation, Public Health
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.
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Recommended Citation
Alexander C Egilman et al, "Transparency of Regulatory Data Across the European Medicines Agency, Health Canada, and US Food and Drug Administration" (2021) 49:3 JL Med & Ethics 456.
Included in
Food and Drug Law Commons, Health Law and Policy Commons, Medical Jurisprudence Commons, Science and Technology Law Commons
