Health Canada recently published a notice to industry detailing its collaborations with international partners during the COVID-19 pandemic. These cooperative efforts aim to ensure that Canadians’ health product needs are being met quickly and effectively during the outbreak, and that Canada’s policies and regulatory strategies are consistent with those in force around the world.
Collaboration with International Regulators
International Coalition of Medicines Regulatory Authorities (ICMRA)
Health Canada is a member of the ICMRA, an entity made up of 29 regulatory authorities and with the World Health Organization (WHO) as an observer. ICMRA members work together to address current and emerging global human medicine regulatory and safety challenges by providing strategic leadership, enabling and facilitating global collaboration mechanisms, and informing and engaging industry stakeholders.
In relation to COVID-19, ICMRA members recommend that new treatments and vaccines be studied in large, well-designed, and robust clinical trials. Further, international collaboration on trials should occur before any new drugs are made widely available. The ICMRA’s recommendations are further detailed in the Coalition’s recent statement.
Australia-Canada-Singapore-Switzerland (ACSS) Consortium
The ACSS Consortium focuses on regulatory collaboration. Thus far, the ACSS Consortium’s COVID-19 discussions have focused on clinical trials for drugs and medical devices and (potential) drug shortages.
Multilateral COVID-19 “Cluster” Meetings
Health Canada participates in regular scientific working-level ‘cluster’ meetings with international partners, including the U.S. Food and Drug Administration and the European Medicines Agency. The cluster meetings facilitate discussions relating to the regulation of various health products. Recently, vaccine cluster meetings have been convened to discuss emerging COVID-19 vaccines and their regulatory requirements.
International Post-Market Surveillance Group
Health Canada is one of several international regulators participating in the International Post-Market Surveillance Group’s teleconferences. The Group monitors the safety of pharmaceutical drugs or medical devices on the market, including COVID-19 products, using information shared by participating agencies.
Medical Dictionary for Regulatory Activities (MedDRA) Management Committee
The MedDRA is a 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. The MedDRA database is currently being updated with COVID-19 terms. The new, common definitions will help ensure consistency in drug safety and efficacy reporting and monitoring efforts throughout the pandemic.
International medical device regulators
Health Canada routinely meets with medical device regulators to exchange best practices and guidance on regulatory authorization pathways, and to discuss any potential shortages. Medical devices include diagnostic tests, personal protective equipment (PPE), and ventilators.
Collaboration with Global Health Organizations
Health Canada is participating in the WHO’s research and development (R&D) blueprint vaccines plan to develop a COVID-19 vaccine. The blueprint is a global strategy and preparedness plan to facilitate the rapid activation of R&D activities during epidemics.
Health Canada is also participating in the WHO’s blueprint vaccines subgroup to keep up to date on any COVID-19 vaccine technologies in development. For instance, the WHO is conducting the international Solidarity clinical trial. Health Canada has also approved a number of Canadian clinical trials.
Pan American Health Organization (PAHO)
PAHO is a specialized international health agency for the Americas. PAHO promotes and engages in technical cooperation with its member countries to: (i) fight communicable and non-communicable diseases and their causes; (ii) strengthen health systems; and (iii) respond to emergencies and disasters.
Health Canada is a member of PAHO’s COVID-19 task group, which consists of representatives from each national regulatory authority in PAHO’s member countries and centres.
For more information on the legal implications of COVID-19, please consult our COVID-19 Hub. As a full service global firm with offices across Canada, Norton Rose Fulbright is closely monitoring this evolving situation over a number of practice areas including employment and labour, risk advisory, banking and finance, corporate, M&A and securities, and dispute resolution and litigation, and across a variety of industries including energy, infrastructure, mining and commodities, financial institutions, life sciences and healthcare, technology and innovation, and transport.