News RSS Bioethics News.

12/12/2017

Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information)

External Link - Source: Government of Canada

Without access to detailed clinical data, health professionals and researchers are unable to perform independent analyses of the evidence underlying published research findings and Health Canada’s regulatory reviews. This approach limits transparency and misses opportunities to promote greater confidence in the oversight of drugs and medical devices. It is also out of step with Health Canada’s key regulatory partners, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration, which have increased clinical data transparency over the past 10 years.