Health Canada’s regulatory response to COVID-19: International engagement
During the COVID-19 pandemic, Health Canada is working closely with domestic and international partners to anticipate and meet Canadians' health product needs. This involves discussing, collaborating and leveraging resources on issues related to:
- clinical trials and investigational testing
- drug and medical device market authorizations
- health product risk assessments
- potential drug and medical device shortages
International collaboration ensures that our policies and regulatory approaches are aligned and that health products are effective and made available to Canadians quickly.
On this page
- Working with international regulators
- International Coalition of Medicines Regulatory Authorities (ICMRA)
- Australia-Canada-Singapore-Switzerland consortium (ACSS)
- Multilateral COVID-19 "Cluster" Meetings
- International Post-Market Surveillance Group
- Medical Dictionary for Regulatory Activities (MedDRA) management committee
- International medical device regulators
- Working with global health organizations
Working with international regulators
International Coalition of Medicines Regulatory Authorities (ICMRA)
Health Canada is an executive committee member of the International Coalition of Medicines Regulatory Authorities (ICMRA). This global coalition of regulatory authorities including the World Health Organization (WHO) as an observer provides strategic leadership to address current and emerging regulatory and safety challenges in human medicines.
Health Canada plays an integral role in setting ICMRA's strategic directions. In response to the COVID-19 pandemic, the ICMRA has expanded its scope of work to provide a global approach for aligning the approaches of regulators to COVID-19 treatments and vaccines. Health Canada leads and contributes to aspects of this work being done.
Once the WHO declared a global pandemic, ICMRA published a statement demonstrating a commitment to strengthen global collaboration in the fight against COVID-19. Health Canada participates in bi-weekly ICMRA policy meetings focused on aligning policy approaches and regulatory agility in response to the pandemic. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) co-chair these meetings. ICMRA members agree that COVID-19 treatments and vaccines should be studied in well-conducted, robust clinical trials. The trials should take place on a global scale with collaboration among different countries before new drugs are made available for broader use. Along with ICMRA members, we published a statement about the global collaboration to facilitate and expedite the development and evaluation of diagnostics and therapeutics, including possible vaccines, against SARS-CoV2.
To help address the public health challenge posed by vaccine hesitancy, Health Canada contributed to work led by ICMRA, to develop 2 statements about confidence in vaccine safety and effectiveness, published by the ICMRA:
Health Canada co-chairs, with the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), the ICMRA COVID-19 working group. This group actions and provides recommendations on priority topics and issues raised during the ICMRA COVID-19 policy discussions by heads of agencies. We also co-chair the ICMRA COVID-19 committee for global regulatory cooperation on real-world evidence and observational research with the EMA. ICMRA members have also agreed on 3 priority areas for cooperation on observational research during the COVID-19 pandemic.
We also contribute to the proceedings of the ICMRA international regulatory workshops on the development of COVID-19 vaccines and treatments. Full reports of these initiatives are found on the ICMRA website.
Following each meeting, COVID-19 meeting reports are published on ICMRA News.
ICMRA meeting reports
- regulatory considerations for anticipated COVID-19 vaccine candidates (March 18, 2020)
- available COVID-19 treatments (non-vaccines) and ongoing and planned clinical trials (April 2, 2020)
- use of real-world evidence and observational studies for regulating COVID-19 health products (April 6, 2020)
- ICMRA aims for international alignment on policy approaches and regulatory flexibility during COVID-19 pandemic (April 16, 2020)
- ICMRA meeting on international alignment during COVID-19 pandemic #2 (April 30, 2020)
- ICMRA meeting on international alignment during COVID-19 pandemic #3 (May 14, 2020)
- ICMRA meeting on international alignment during COVID-19 pandemic #4 (May 27, 2020)
- ICMRA meeting on international alignment during COVID-19 pandemic #5 (June 12, 2020)
- Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines (June 22, 2020)
- Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials (July 20, 2020)
- Global regulatory workshop on COVID-19 real-world evidence and observational studies (July 22,2020)
Australia-Canada-Singapore-Switzerland consortium (ACSS)
The Australia-Canada-Singapore-Switzerland (ACSS) consortium fosters regulatory collaboration to address emerging scientific and regulatory issues on health products. The consortium also leverages resources and expertise. ACSS regulators have published a statement pledging support to tackle COVID-19.
To address this worldwide public health crisis, ACSS members are collaborating to advance the regulatory science needed to support the rapid development of diagnostic tests, as well as vaccines and treatments against COVID-19. Consortium members remain committed to review and collaborate on possible COVID-19 investigational vaccines and treatment options, with the goal of expediting their development.
Multilateral COVID-19 'cluster' meetings
We also participate in regular scientific working-level meetings with several international partners, such as the U.S. FDA and EMA. These 'cluster' meetings are held to discuss topics related to the regulation of various health products. Regular cluster meetings focus on topics such as:
Recent meetings of these clusters have focused on issues related to COVID-19. In particular, the vaccines cluster is being leveraged to discuss emerging COVID-19 vaccines and associated regulatory requirements.
International Post-Market Surveillance Group
Health Canada participates in teleconference meetings of the International Post-Market Surveillance Group, along with several international regulators. This group monitors the safety of pharmaceutical drugs or medical devices on the market, including products used for COVID-19.
Through an information-sharing network, participating agencies exchange information on COVID-19 post-market health product safety issues. This is critical, particularly when important statements or communications on COVID-19 have to go out quickly.
Medical Dictionary for Regulatory Activities (MedDRA) management committee
The Medical Dictionary for Regulatory Activities (MedDRA) is a rich, very specific, standardized medical dictionary developed by the International Council for Harmonisation (ICH). Health Canada is a member of the MedDRA management committee and a standing member of ICH.
A large number of terms specific to COVID-19 are being added to the MedDRA database. Common definitions are used to ensure consistency in activities like adverse event reporting. This helps industry and regulators more effectively monitor the safety of drugs throughout their lifecycle, from clinical trials to post-market surveillance.
We have updated our notice to industry to incorporate these updates.
International medical device regulators
We meet regularly with other trusted regulators to exchange best practices and published guidance on regulatory pathways for medical device authorization. We also discuss potential medical device shortages with our international partners. This work covers diagnostic tests, personal protective equipment and ventilators.
Working groups are established as needed to discuss specific issues, like the minimum requirements for serological tests.
Interim Order provisions allow for:
- designated medical devices to be imported quickly
- timely scientific review of submissions for medical devices
- leveraging authorization of trusted regulators, such as the U.S. FDA
Working with global health organizations
World Health Organization (WHO)
We are participating in the World Health Organization's (WHO) research and development (R&D) blueprint vaccines plan to develop a COVID-19 vaccine. Our contributions include helping to develop the blueprint, a global strategy and preparedness plan. This is designed to help countries quickly undertake R&D activities during epidemics.
We are also participating in the WHO's blueprint vaccines subgroup to keep up to date with COVID-19 vaccine technologies being developed. International collaboration on COVID-19 vaccine development is highlighted in WHO's declaration.
Pan American Health Organization (PAHO)
The Pan American Health Organization (PAHO) is an international health agency for the Americas. It specializes in engaging in technical cooperation with member countries to:
- fight communicable and non-communicable diseases and their causes
- strengthen health systems
- respond to emergencies and disasters
PAHO's national regulatory pandemic response framework helps to guide the PAHO region during a pandemic. Health Canada is a member of its COVID-19 task group, which consists of representatives from each national regulatory authority in the PAHO region.
- Canada and international partners launch the Coronavirus Global Response
- International Coalition of Medicines Regulatory Agencies (ICMRA)
- Australia-Canada-Singapore-Switzerland (ACSS) consortium
- Health Canada International Activities
- Pan American Health Organization (PAHO)
- Medical Dictionary for Regulatory Activities (MedDRA)
- COVID-19 health product industry
- Coronavirus disease (COVID-19): For health professionals
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