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:
- Health Canada published the Public Release of Clinical Information: guidance document to help explain aspects of the new regulations, such as:
- the procedures to prepare information for release;
- the categories of information that continue to be subject to the definition of 'confidential business information' and that may be eligible for redaction; and
- the protection of personal information.
The draft guidance was previously published in April 2018.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.
- Clinical information about drugs and medical devices can now be accessed on Health Canada's Clinical Information Portal.
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:
- clinical information that was not used by the manufacturer in the drug submission, drug supplement or medical device application to support the proposed conditions of use or the purpose for which the drug or medical device is recommended; or
- clinical information that describes tests, methods or assays used exclusively by 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").
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