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
- European Medicines Agency OPEN Project
- International Coalition of Medicines Regulatory Authorities (ICMRA)
- Access Consortium
- 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
European Medicines Agency OPEN Project
As of December 18, 2020, Health Canada is participating in the pilot phase of the European Medicines Agency's (EMA) "Opening our Procedures at EMA to Non-EU authorities (OPEN)" project. This initiative makes it possible for trusted regulatory authorities outside of the European Union, such as Health Canada, to collaborate with the EMA. Health Canada supports international collaboration, which helps to strengthen regulatory capacity and increase the availability of medicines.
As part of this pilot, Health Canada will be able to participate in EMA's assessment process for COVID-19-related medicinal products, including vaccines. This initiative will promote overall transparency and contribute to public trust in vaccines and therapeutics. The pilot will foster better understanding and outcomes, while retaining scientific and regulatory independence of the participating authorities.
Through this project, Health Canada looks forward to contributing to discussions involving the:
- Committee for Medicinal Products for Human Use (CHMP)
- Emergency Task Force concerned with the rolling review of COVID-19 applications
At this stage, regulators from Australia, Japan, Switzerland and the World Health Organisation are also participating in OPEN.
For more information on OPEN, please see EMA's website.
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 this work.
Once the WHO declared a global pandemic, ICMRA published a statement committing to strengthen global collaboration in the fight against COVID-19. Due to the large number of COVID-19 vaccines and treatments under development, the WHO and ICMRA published a joint statement. This statement commits to uphold and promote the most rigorous, evidence-based regulatory practices by supporting the alignment of regulatory processes across all countries.
Health Canada participates in 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.
Health Canada co-chairs the ICMRA COVID-19 working group with the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). This group provides and actions 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.
Along with ICMRA members, Health Canada has collaborated with our international partners to publish statements on COVID-19 diagnostics, therapeutics, clinical trials, and vaccine confidence. These statements provide important COVID-19 information to a wide variety of audiences:
- ICMRA statement on clinical trials (June 24, 2020)
- Statement on continuation of vaccine trials (November 27, 2020)
- Statement on confidence in vaccine safety and effectiveness for health care professionals (June 27, 2020)
- Statement on confidence in vaccines for the general public (June 27, 2020)
- Statement for healthcare professionals on how COVID-19 vaccines will be regulated (January 19, 2021)
- Revised: Statement for healthcare professionals on how COVID-19 vaccines will be regulated (June 11, 2021)
- Statement for need on continued focus on COVID-19 therapeutics (December 10, 2021)
Information on vaccines and treatments authorized for COVID-19 can be found on Canada's COVID-19 vaccines and treatments portal. Weekly updated information about any adverse events that individuals have experienced following COVID-19 vaccine immunization can be found in the COVID-19 Vaccine Safety Report.
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.
This pandemic has underscored the importance of cooperation and information sharing between multiple regulatory authorities during a public health emergency. See related statements and reports below:
- Statement from global medicines regulators on the value of regulatory reliance (November 27, 2020)
- Statement on global regulators' commitment to cooperate on observational research in the context of COVID-19 (May 19, 2020)
- Joint ICMRA and WHO statement on transparency and data integrity (May 7, 2021)
- Statement on pre-requisites for regulatory flexibility in pharmaceutical manufacturing change (October 12, 2021)
- ICMRA-Industry virtual workshop report on enabling manufacturing capacity in the COVID-19 pandemic (July 7-8, 2021)
- Report on the review of COVID-19 regulatory flexibilities / agilities by National Regulatory Authorities (December 3, 2021)
- Reflections on remote GCP and GMP regulatory oversight inspections (December 10, 2021)
- Deep dive report: Review of provisions and procedures for emergency use authorization of COVID-19 medical products (December 10, 2021)
If you are interested in reading more about ICMRA's various meetings and workshops, please visit the ICMRA COVID-19 page, which is updated regularly with new statements and reports.
The Access consortium fosters regulatory collaboration to address emerging scientific and regulatory issues on health products. The consortium also leverages resources and expertise.
To address this worldwide public health crisis, Access 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 COVID-19 vaccine candidates and treatment options, with the goal of expediting their review and availability on the market. Building on the pledge to work together to counter the COVID-19 global pandemic, Access regulators have published the following statements and guidance:
- statement on COVID-19 medicines
- statement pledging support to tackle COVID-19
- statement on COVID-19 vaccine evidence
- statement on alignment with IMCRA consensus on immunobridging for authorizing new COVID-19 vaccines
- guidance on modifications to COVID-19 vaccines to address new variants of coronavirus
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. At these 'cluster' meetings, the partners discuss 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.
- Statement about confidence in COVID-19 vaccines for health care professionals
- Canada and international partners launch the Coronavirus Global Response
- International Coalition of Medicines Regulatory Agencies (ICMRA)
- Access 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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