March 2019: Canada Update

Health Canada regulation on “public access to clinical information on drugs and medical devices” is published

March 20, 2019: New amendments to the Food and Drug Regulation and the Medical Devices Regulations are published in the Canada Gazette. These amendments regarding the disclosure of clinical trial information will now allow the public release of clinical information on drugs and medical devices.

The information submitted to Health Canada in a drug submission, namely clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission, was considered as confidential business information (CBI). Now, such information will no longer be treated as confidential following a final regulatory decision and will be released to the public.

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