Canada finally opens up data on new drugs and devices: Other regulators should take note of Health Canada’s substantive reforms
Description
Authors discuss Health Canada’s revised regulations regarding releasing detailed clinical information about new drugs, biological treatments, and medical devices. They contrast the policies of the Canadian regulator and its European counterpart, the European Medicines Agency (EMA), with that of the US Food and Drug Administration (FDA) which has yet to demonstrate a similar commitment to transparency.Keyword
clinical study reportsdata access policies
research transparency
Information Dissemination--legislation & jurisprudence
Canada. Health Canada
European Medicines Agency
United States. Food and Drug Administration
Identifier to cite or link to this item
http://hdl.handle.net/10713/8860ae974a485f413a2113503eed53cd6c53
10.1136/bmj.l1825