Potential Change in Store for Regulating Disclosure of Clinical Information
On December 9, the Government of Canada published proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (Regulations).1 2 If brought into force, these amendments will permit Health Canada to publicly disclose clinical information in drug submissions for human use and medical device applications after a final regulatory decision has been made.
The amendments to the Regulations will help bring Health Canada's approach to disclosure in line with that of the European Medicines Agency and the U.S. Food and Drug Administration, both of which have increased clinical data transparency over the past decade.
What You Need To Know
When will clinical information be made public?
- Clinical information provided in drug submissions will be made public once the marketing authorization for the drug is issued or a drug submission has been deemed to be withdrawn.
- Clinical information provided in medical device applications will be public once a medical device licence is granted or a refusal letter is issued.
What clinical information will be made public? If the proposal is brought into force, the following information would no longer be considered confidential business information (CBI):
- Clinical summaries;
- Reports and supporting data of clinical trials submitted in support of a drug submission; and
- Reports and supporting data of clinical trials or investigational testing in humans submitted in support of any Class III or Class IV medical device application.
What information will continue to be treated as confidential? Exempt information which would continue to be treated as CBI includes:
- Information not used by the manufacturer in a drug submission to support the proposed conditions of use and purpose for the drug;
- Information not used by the manufacturer in a medical device application to support the conditions, purposes and uses for which the device is manufactured, sold or represented; and
- Information that describes tests, methods or assays that are used exclusively by the manufacturer.
Health Canada will allow manufacturers to propose redactions on any information within a submission that should remain confidential based on the exemptions in the Regulations. However, Health Canada will have the authority to disclose any information that is no longer considered CBI without notifying the manufacturer or receiving their consent.
Grandfathering: The proposed Regulations will apply to the following clinical information, which will be disclosed.
- Information in submissions for drugs or medical devices which have already received marketing authorizations would not be grandfathered and will be subject to the new law.
- Information in submissions for drugs or medical devices which have already been deemed to be withdrawn by Health Canada would not be grandfathered and will be subject to the new law.
What's Next?
Health Canada is accepting public comments on the proposed Regulations until February 22, 2018 and is seeking recommendations from an external stakeholder group on the proposed implementation plan with the intention of publishing a draft guidance document for consultation before February 22, 2018. The final guidance document will be available when the proposed Regulations come into force.
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1 See: http://www.gazette.gc.ca/rp-pr/p1/2017/2017-12-09/html/reg3-eng.html.
2 See: http://www.gazette.gc.ca/rp-pr/p1/2017/2017-12-09/html/reg4-eng.html.
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