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Proposal to proactively release clinical data after completion of RxIP - Regulatory review process, and final guidance on disclosure of confidential business information

Health Canada has proposed to proactively make certain clinical information about the safety and efficacy of drugs and medical devices available to the public once the RxIP - Regulatory review process is complete. To that end, Health Canada released the white paper Public Release of Clinical Information in Drug Submissions and Medical Device Applications in March. The white paper “sets out the policy objectives, rationale and considerations for future regulations that would specify that certain clinical information contained in drug submissions or medical device applications would not be treated or cease to be confidential business information following a final RxIP - Regulatory decision and that would authorize the public release of that information.” Interested parties have until May 26, 2017 to provide feedback on the white paper. Health Canada has also released the final guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act. Health Canada also maintains a list of completed requests for disclosure of confidential business information (CBI). CBI was disclosed in response to two of the twelve completed requests in 2015 and 2016.