On March 10, Health Canada released a white paper entitled "Public Release of Clinical Information in Drug Submissions and Medical Device Applications."1 If adopted, the recommendations of the white paper would allow Health Canada to disclose specified clinical information in drug submissions and medical device applications for non-commercial purposes.
What You Need To Know
- Public release of clinical information in drug submissions and medical device applications would be limited to those that have completed Health Canada's regulatory review process.
- Certain categories of commercial information included in the drug submission or medical device application may be exempt from public release. Health Canada will consider these exemptions upon discussion with manufacturers.
- Certain portions of the methodological details for drugs and medical devices may be treated as confidential, including in-house modifications or procedures to analytical, immunogenicity, bioassay, or sample size calculations methods not commonly used by the industry.
- The recommendations are proposals only. Comment is open on the proposals until May 26, 2017.
- Health Canada is targeting to release draft regulations in the fall of 2017.
Health Canada has been making more data about health products available to the public in recent years as part of its Regulatory Transparency and Openness Framework. This white paper works to support this initiative as Health Canada looks to align its disclosure policies with that of the European Medicines Agency (EMA) and the U.S. Food and Drugs Administration (US FDA). The EMA has released clinical trial data for medicines on request under its access to document policy since 2010, and since October 2016 has been publishing clinical data submitted after January 1, 2015 by pharmaceutical companies to support regulatory applications they have submitted for human medicines.2 In that same vein, the U.S. FDA issued the final rule3 on September 21, 2016 that expands the requirements for the submission of clinical trial registration and results information to improve public access to information. Most notably, the final rule requires that results information is required for all applicable clinical trials of drugs, biologics, and medical devices that are approved, licensed, or cleared, in addition to those that are not approved, licensed or cleared by the U.S. FDA. The final rule came into effect January 18, 2017.
Health Canada recently amended the Food and Drugs Act to permit the disclosure of Confidential Business Information (CBI) without notice in situations where a therapeutic product may present a serious risk of injury, or if the proposed disclosure is in the interest of human health or public safety. With respect to the latter, Health Canada may only disclose CBI to (i) certain government bodies, (ii) persons from whom Health Canada seeks advice and (iii) persons who carry out functions relating to human health and public safety promotion. In conjunction with the white paper, Health Canada released a Guidance Document on the current process for disclosure of CBI4 – however, if the proposal to release clinical information is enacted, such clinical information will cease to be CBI and as such, will no longer be subject to a vetting process prior to its release.
Health Canada is accepting public comments on the proposal until May 26, 2017. Written submissions will be available following completion of the public comment period. Health Canada intends to propose draft regulations in the fall of 2017, which will be followed by further public consultations.
2 Clinical Data Publication, online: European Medicines Agency: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000555.jsp&mid=WC0b01ac05809f363e.
3 Clinical Trials Registration and Results Information Submission, online: Office of the Federal Register: https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission.
4 Draft Guidance Document, Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act, online: Government of Canada: https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/request-disclosure-confidential-business-information/disclosure-confidential-business-information/guidance.html#disclosure.
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