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24 April 2019
On 4 March 2019 the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information) (collectively, the regulations) came into force. The regulations were pre-published for comment (in substantially the same form) on 9 December 2017 (for further details please see "Health Canada issues guidance on use of foreign-sourced reference products as CRPs").
The regulations seek to provide public access to clinical information submitted to Health Canada for drugs for human use and medical device applications. Following a final regulatory decision, clinical trial information will cease to be confidential business information and the release of this information will not require notice to the affected party.
As a result of the final regulations' release, Health Canada published the following:
The draft guidance was previously published in April 2018. The final guidance further outlines the procedure for sponsors to initiate a one-on-one process initiation meeting to consult with Health Canada on the clinical documents within the scope of release and to provide an opportunity to clarify Health Canada's requirements and process, as outlined in Section 4.1.
According to the guidance document, Health Canada intends to proactively publish clinical information for submissions that receive a final regulatory decision after the regulations came into force. Proactive publication will be phased in over four years, according to the schedule in Section 3.3 of the guidance document. Drug submissions and medical device applications that received a final regulatory decision before the regulations came into force will be released on request.
In addition, Health Canada will protect the following information from public release, with valid justification from the manufacturer:
These regulations are one of the measures under Vanessa's Law intended to increase transparency (for further details please see "Update on Vanessa's Law").
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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