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07 February 2018
On December 9 2017 – following the release of a white paper in March 2017 – Health Canada released proposed amendments to the Food and Drug Regulations. Under the amendments, "clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission" would cease to be treated as confidential and would be released to the public following a final regulatory decision. Analogous amendments are proposed to the Medical Devices Regulations for Class III and IV medical device applications. Release would not require notice to the affected party.
Exceptions would be made for information that:
For these exceptions only, manufacturers would have an opportunity before publication to propose redactions for consideration by Health Canada. The proposed amendments would apply to clinical information in drug submissions and medical device applications filed both before and after they come into force. Comments will be accepted until February 22 2018.
For further information on this topic please contact Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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