In December 2017, Health Canada proposed draft regulations to support the public release of clinical information in drug submissions and medical device applications. Under the amendments, “clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission” would no longer be treated as confidential and would be released to the public, following a final regulatory decision. Similar amendments have been proposed for the Medical Devices Regulations for Class III and IV medical device applications.
Exceptions would be made for information that:
- the manufacturer did not use in the drug submission or medical device application to support the proposed conditions of use or purpose of the drug or medical device; or
- describes tests, methods or assays that are used exclusively by the manufacturer
Health Canada is currently holding a consultation before these amendments come into force.