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Statement from Health Canada on the publication of a white paper on Public Release of Clinical Information in Drug Submissions and Medical Device Applications

OTTAWA, March 9, 2017 /CNW/ - Health Canada recognizes 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.

Improving access to this information would also make Health Canada more accountable for its decisions and enable closer public scrutiny of researchers' and product sponsors' findings. In addition, Health Canada's approach would be better aligned with the policies of forward-thinking international regulators, including the European Medicines Agency and the US Food and Drugs Administration.

Canadians have 75 days to provide their feedback on the white paper.

Health Canada is also publishing the final guidance document on Disclosure of Confidential Business Information under the Food and Drugs Act.

This guidance applies to Health Canada's existing authority to disclose confidential business information regarding therapeutic products. It would continue to apply to other confidential business information that would not become publicly available as a result of the proposal in the white paper on Public Release of Clinical Information in Drug Submissions and Medical Device Applications.

This guidance document is part of Health Canada's existing Regulatory Transparency and Openness Framework. Through the Framework, Health Canada has committed to providing Canadians greater access to credible, timely and useful information to allow them to make well-informed decisions concerning their health and that of their families.  

Associated Links:

Draft Guidance Document – Disclosure of Confidential Business Information under the Food and Drugs Act