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Proposed amendments to Food and Drug Regulations and the Medical Devices Regulations to publicly release clinical data after completion of RxIP - Regulatory review process

Following release of a white paper in March, on December 9, 2017, Health Canada released proposed amendments to the Food and Drug Regulations under which “clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission” would cease to be treated as confidential and released to the public following a final RxIP - Regulatory decision. Analogous amendments are proposed to the Medical Devices Regulations for Class III or IV medical device applications. Release would not require notice to the affected party.

Exception would be made for:

  1. information that the manufacturer did not use in the drug submission or medical device application to support the proposed conditions of use or purpose for the drug or medical device; or
  2. information that describes tests, methods or assays that are used exclusively by the manufacturer.

For these exceptions only, the manufacturer would have the opportunity to propose redactions before publication, to be considered 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 received until February 22, 2018.