Statement from Health Canada on the publication of a white paper on public release of clinical information in drug submissions and medical device applications

Health Canada

9 March 2017 - Health Canada recognises that access to clinical information can help health researchers and practitioners, improve patient safety and health outcomes for Canadians. 

To that end, Health Canada is proposing to proactively make certain clinical information from drug submissions and medical device applications publicly available following the completion of its regulatory review process. Once a final decision is reached on a drug submission or medical device application, clinical information would no longer be confidential business information and would be proactively released to the public. The Department has released the white paper Public Release of Clinical Information in Drug Submissions and Medical Device Applications which sets out the policy rationale and proposed approach for future regulatory development that would allow this to happen.

This approach would support Canada’s Open Government initiative to create greater transparency and accountability, increase citizen engagement, and drive innovation and economic opportunities through open data, open information, and open dialogue.

Read Health Canada press release 

Michael Wonder

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Michael Wonder