On August 23, 2021, Health Canada posted an update on the consultation paper
that was released on May 20, 2021. This consultation paper focuses on the key policy proposals to modernize Canada’s clinical trials regulatory framework. One of the points discussed was clinical trial transparency. Along with the consultation paper, an online questionnaire was provided to seek feedback from the interested industry and non-industry stakeholders including all interested Canadians.
Interested stakeholders could refer to the consultation paper and send feedback either via an online questionnaire or by sending a written submission by email. The consultation feedback ran from May 20, 2021, till July 04, 2021.
The feedback received during this consultation will help make a decision with respect to outstanding proposed regulatory policy, and program consideration for each product line in the future.
A summary report on the discussions and comments received named “What we heard” is planned to be published in fall 2021.
Health Canada launched a consultation paper on May 20, 2021. This paper outlines the key policy proposals for the modernization of Canada’s clinical trials regulatory framework. One of the points discussed is clinical trial transparency.
Currently, Health Canada’s Clinical Trials Database provides information related to Phase I, II and III clinical trials involving drugs and conducted in patients. Health Canada also encourages the sponsors to register the clinical trials on public registries like ClinicalTrials.gov and ISRCTN. Health Canada is examining options for how to best design and implement measures to promote the registration of Canadian clinical trials in public registries as well as public disclosure of the results (results reporting). These measures may include the development of new policies and regulations while making clinical trial information more accessible to the public with help of information technology such as artificial intelligence (AI).
One approach being considered would be to develop a new policy that would guide sponsors step by step with processes related to registration and results reporting. Alternatively, the department could begin with new regulatory requirements for registration in the initial phase, with policy measures to address results reporting.
Some of the elements of registration and results reporting under consideration are outlined below:
Health Canada is exploring policy and regulatory options for the registration of authorized Canadian clinical trials investigating drugs, medical devices and natural health products (NHPs). Canadian trial sponsors may be asked to register their trials in an existing, international registry that has been deemed eligible by the department within a prescribed timeframe. The trial sponsor might also be asked to notify Health Canada with proof of their registration (e.g., registry link and trial identifying number), within a certain timeframe after completing registration.
Public Disclosure of Results
Health Canada is also exploring policy and regulatory options for the requirement of public disclosure or reporting of trial results. This would mean that Canadian trial sponsors would be asked to publicly report trial results, and may be asked to notify Health Canada within prescribed timeframes once the results have been made public.
As per the Forward Regulatory Plan 2021-2023: Modernization of the Regulation of Clinical Trials, published on April 01, 2021, Health Canada is proposing to amend sections of the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices Regulations.
This proposal along with aligning the regulatory framework for clinical trials in Canada will also align Canada with global best practices regarding oversight and public access to information on clinical trials.
Health Canada published a guidance document, Public release of clinical information for drugs and medical devices in COVID-19 interim orders applications on October 07, 2020.
The document explains the process for the public release of safety and efficacy/effectiveness information reviewed under ‘interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (September 16, 2020)‘ and ‘interim order respecting the importation and sale of medical devices for use in relation to COVID-19(March 18, 2020)‘. Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. Information in applications that are refused and were never authorized is out of scope for public release.
A final redacted and anonymized package is published on Health Canada’s Clinical Information Portal within 120 calendar days from the day an authorization is issued. This process is in accordance with the timelines given in the Public Release of Clinical Information (PRCI) guidance document.
Publication of safety and efficacy information used to support drug interim order applications
- The first 60 days of the 120-day publication process are allocated for the company to review the clinical information. The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of confidential business information (CBI).
- Within 30 days of receiving the proposal package, Health Canada will complete and return the assessment of the proposed CBI redactions and anonymization methodology for the protection of personal information.
- The manufacturer will be given 15 days to make the revisions and resubmit.
- The final assessment will be sent to the manufacturer within 5 days of receiving the revised package.
- The manufacturer must format and submit the final redacted and anonymized clinical documents within 5 days of receiving the final assessment.
- The final redacted documents will be published within 5 days of receiving the final sequence.
Publication of safety and effectiveness information used to support medical device interim order applications
- The CBI and personal information from the interim order application, for which information request is received, will be assessed and redacted by Health Canada.
- A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.
- Any further redactions proposed by the manufacturer will be assessed.
- In-scope documents will be published within 120 days following receipt of the request.
On April 08, 2020, Ropes & Gray published a document comparing the guidance documents related to COVID-19, its impact on and additional requirements for conducting the clinical trials. The guidance documents involved are issued by the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”), Switzerland’s Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”), Health Canada, and Singapore Health Sciences Authority (“HSA”).
Earlier, on April 02, 2020, a comparative chart was published summarizing the guidance documents issued by FDA, EMA, MHRA and PMDA.
The comparisons include initiating a new clinical trial, continuing a clinical trial, any changes (amendments) to a clinical trial, informed consent changes, study visits, COVID-19 screening procedures, monitoring
activities, investigational product distribution and study reporting.
Health Canada regulation on “public access to clinical information on drugs and medical devices” is published
March 20, 2019: New amendments to the Food and Drug Regulation and the Medical Devices Regulations are published in the Canada Gazette. These amendments regarding the disclosure of clinical trial information will now allow the public release of clinical information on drugs and medical devices.
The information submitted to Health Canada in a drug submission, namely clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission, was considered as confidential business information (CBI). Now, such information will no longer be treated as confidential following a final regulatory decision and will be released to the public.
Health Canada finalizes regulations to provide public access to clinical information on drugs and medical devices
Health Canada regulation on “public access to clinical information on drugs and medical devices” is finally going to be published on March 20,2019 as per their Press release dated 13 Mar 2019.
On March 20, 2019, Health Canada will publish final regulations that allow for the public release of clinical information on drugs and medical devices. Clinical information is the data that companies provide when requesting authorization of these products, and includes study reports and clinical trial results. These regulations are one of the key transparency measures introduced under Vanessa’s Law.
Clinical information will be made available to Canadians through Health Canada’s new Clinical Information Portal as of March 13, 2019.
Proactive disclosure for medical devices will start in 2021, to coincide with steps the European Union is taking to increase the transparency of clinical information for medical devices, and to reduce the burden on stakeholders by aligning approaches”
Press release: www.canada.ca/en/health-canada/news/2019/03/…
Link to Health Canada’s new portal: clinical-information.canada.ca/search/ci-rc