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:

International collaboration ensures that our policies and regulatory approaches are aligned and that health products are effective and made available to Canadians quickly.

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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:

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 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 available to the public . 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.

ICMRA members have also published a statement on the continuation of vaccine trials. Continuing COVID-19 vaccine trials for as long as necessary will enable us to collect critical data that can help to inform future regulatory actions. These data can provide important additional and more precise information on the longer-term safety and efficacy of a vaccine against COVID-19.

To help address the public health challenge posed by vaccine hesitancy, Health Canada helped   develop 2 statements about general confidence in vaccine safety and effectiveness, published by the ICMRA:

ICMRA published a statement directed to health care professionals about confidence in COVID-19 vaccines. ICMRA and WHO followed up with a joint, updated statement to help health care professionals answer questions about COVID-19 vaccines. Both statements explain how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety will continue to be closely monitored after a vaccine is approved. This recent joint statement also explains how COVID-19 vaccines are effective against variants.

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.

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.

This pandemic has underscored the importance of cooperation and information sharing between multiple regulatory authorities during a public health emergency. Health Canada has helped develop a statement from global medicines regulators on the value of regulatory reliance. We also helped develop a joint statement on transparency and data integrity. The statement calls on the pharmaceutical industry to provide wide access to clinical data for all new COVID-19 medicines and vaccines. This includes those that have received full or conditional approval, under emergency use or have been rejected.

Following each meeting, COVID-19 meeting reports are published on ICMRA News.

ICMRA meeting reports

Access consortium

The Access consortium fosters regulatory collaboration to address emerging scientific and regulatory issues on health products. The consortium also leverages resources and expertise. Access regulators have published a statement pledging support to tackle COVID-19.

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 a statement on COVID-19 vaccines evidence. Access Consortium partners have developed 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:

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.

The WHO is conducting the Solidarity trial, an international clinical trial of candidate vaccines against COVID-19. Health Canada has also approved a number of Canadian clinical trials.

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:

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.

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