Drugs and Medical Devices (ICS: 11.120; 11.040)

Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) (16 pages, in English and French)

In 2014, the Protecting Canadians from Unsafe Drugs Act amended the Food and Drugs Act regarding drugs and medical devices in order to improve safety by introducing measures to, among other things:

1.    strengthen safety oversight of therapeutic products throughout their lifecycle;

2.    improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and

3.    promote greater confidence in the oversight of therapeutic products by increasing transparency.

Most information related to clinical trials that is submitted to Health Canada in drug submissions and medical device applications has typically been treated as confidential business information (CBI). This information is used to assess the safety and efficacy of a drug in humans, and the safety and effectiveness of medical devices. In order to promote greater confidence in the regulatory oversight of drugs and medical devices new transparency-related regulation-making authorities brought in 2014 permit the Governor in Council to make regulations that specify that certain information obtained under the Act that is not Confidential Business Information (CBI) or the circumstances in which it ceases to be CBI. The regulation-making authorities also permit the making of regulations that allow the release of this information.