欧洲药品管理局、加拿大卫生部和美国食品药品监督管理局的监管数据透明度。
Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.
出版信息
J Law Med Ethics. 2021;49(3):456-485. doi: 10.1017/jme.2021.67.
PMID:34665102
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.
摘要
基于对相关法律法规、监管机构数据门户和信息请求的分析，我们发现，向欧洲药品管理局和加拿大卫生部提交的用于支持药品批准的临床数据，包括临床研究报告，通常会被公开。
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