2021-2022 Raison d'être, mandate and role: who we are and what we do - Health Canada
Raison d'être
Health Canada regulates specific products and controlled substances and supports innovation and information sharing in Canada's health system to help Canadians maintain and improve their health.
Mandate and role
At Health Canada, our role is to help Canadians maintain and improve their health. While the provinces and territories are responsible for delivering health care to the majority of Canadians, the federal government also has a number of key roles and responsibilities in areas that affect health and health care. In addition to working closely with provincial and territorial governments, we also work with partners in the Health Portfolio (Public Health Agency of Canada, Canada Food Inspection Agency, and Canadian Institutes of Health Research), other federal departments and agencies, non-governmental organizations, other countries, Indigenous partners and the private sector.
As a partner in health, Health Canada:
- protects Canadians from unsafe food, health and consumer products;
- promotes innovation in health care; and,
- informs Canadians to make healthy choices.
The meals we serve our families, the pesticides farmers put on crops, the herbal remedies, vitamins and drugs in our medicine cabinets, the toys we buy our children - they are all products regulated by Health Canada for safety. Hundreds of new products, with new ingredients and new purposes, are introduced by industry every year in Canada. Health Canada's decisions are made with the best interest of Canadians in mind, whether to approve the safety and quality of new products or to provide advice after they are on the market. Our actions are supported by scientific evidence.
Our Department is committed to upholding the Canada Health Act and protecting our publicly funded health care system, which helps to ensure Canadians have access to quality, universal health care based strictly on their medical needs, not their ability and willingness to pay. We also promote innovation and the use of best practices across Canada.
Health Canada's vision is to help make Canada's population among the healthiest in the world. From coast to coast to coast, Health Canada employees - scientists and researchers, inspectors, doctors and nurses, policy analysts and administrative professionals, and many others - are working to help Canadians maintain and improve their health.
As a regulator, service provider, promoter of innovation, and trusted source of information, we are a partner in health for all Canadians.
For more information on the Department's organizational mandate letter commitments, see the Ministers' mandate letters.
Operating Context
Health Canada operates in a complex and dynamic environment, facing several challenges as it works to deliver results for Canadians. Many of these challenges – such as the COVID-19 pandemic and the overdose crisis – are beyond the sole control of the Department and involve working collaboratively with federal, provinces and territories partners (F/P/Ts), Indigenous organizations, industry and international regulators.
Responding to the COVID-19 pandemic
The emergence of COVID-19 variants continued to challenge Canadians and health systems across the country. The pandemic continued to negatively affect the mental health of many Canadians; disproportionally impacted those living in long-term care homes; worsened the overdose crisis; increased the demand for key drugs used to treat COVID-19, and intensified the demand for surge capacity for front line workers and scientific experts.
Health Canada leveraged its resources to minimize the impacts of COVID-19 on Canadians' health and safety. Procuring and distributing rapid antigen tests, authorizing COVID-19 vaccines, including boosters, supporting P/Ts through targeted investments in mental health, virtual care, and long-term care, and creating a stockpile of critical drugs to support critically ill COVID patients remained key priorities for the Department.
Strengthening the health care system
Canada's health system is experiencing an unprecedented Health Human Resource crisis. High patient workloads, challenging work conditions, and concerns for personal safety have led to high levels of burnout, absences, and turnover. Canadians are feeling the impacts as emergency rooms are overwhelmed, and in some cases closing temporarily; many Canadians still lack a primary care provider; and wait times continue to increase across the health system.
Health Canada worked with provinces and territories (P/Ts) to increase the Health Human Resource workforce, collect better data to enable workforce planning and find innovative approaches to enhance the efficiency of the workforce and the health care system. The Department reinstated the Chief Nursing Officer to provide federal leadership on nursing issues going forward.
Addressing the overdose epidemic
The COVID-19 pandemic especially affected populations at higher risk. It created new barriers and challenges for those already experiencing mental illness and substance use issues. Addressing these challenges required a collaborative approach between all orders of government and other partners. For example, the Department implemented a number of regulatory flexibilities to support Canadians, stakeholders and industry during the pandemic (e.g., facilitated access to treatment services for substance use, and facilitated the rapid establishment of overdose prevention sites).
Guided by the federal Canadian Drugs and Substances Strategy, Health Canada developed a public health-focused approach to the overdose crisis. The Department supported community-led initiatives, such as: facilitating access to mental health and addiction support services, providing regulatory approval for supervised injection sites and facilitating access to safer supply services, and strengthening overdose prevention efforts, including increased access to naloxone kits.
Building an agile and inclusive workforce
Health Canada employees began gradually re-entering the workplace while respecting public health guidelines and safety measures. This provided an opportunity to explore both the longer-term future of work and organizational resiliency in the context of lessons learned from the COVID-19 pandemic. IT systems and tools were re-configured to support employees both working at home and in the office and comprehensive strategies to protect public servants' mental health and wellness were maintained.
The Department's values – fostering a diverse and inclusive workplace that is free of racism and discrimination and where all employees are treated with respect, dignity and fairness – formed the foundation of who we are, what we do, and how we do our work.
Regulating in the context of a global supply chain
The increased pace of scientific and technological innovation, globalization, and the complexity of the global supply chain were key challenges for regulators. Effectively regulating new, innovative and complex products, substances, food and emerging product categories in a global marketplace required a global approach. As such, the Department focused on building and strengthening relationships with domestic and international partners to leverage cooperation and best practices, and accelerate regulatory reviews.
Providing timely, trusted and evidence-based information
The Department continued to provide high quality, scientific and evidence-based health information through a range of online and traditional communication tools and channels. This was critical to helping Canadians make informed health decisions, especially when there was an increasing amount of information available to the general public of varying levels of scientific quality and accuracy.
Further, Canadians expected their Government to be open and transparent and effectively engage them in decision-making. Clarity on direction and sharing timely information with stakeholders and the public helped ensure that the Department was viewed as a trusted source of information.
Canadians also expected that their privacy be protected while accessing government sources and platforms. Health Canada adhered to privacy provisions and ensured that Canadians' personal information was secured.
Key Risks
Health Canada has a well-established risk management process that enables the Department to respond proactively to change and uncertainty by understanding and monitoring its operating environment and the factors that drive risks.
Key Risk for Core Responsibility 1: Health Care Systems
| Risk Responses | Link to the Department's Core Responsibilities | Link to Mandate Letter Commitments or Government-Wide Priorities |
|---|---|---|
| Fostered engagement and collaboration | Core Responsibility 1: Health Care Systems |
Mandate Letter Commitment: Continue to work in close collaboration with P/Ts, municipalities, Indigenous communities and other partners to increase COVID-19 testing and tracking; support the availability of rapid tests and self-tests; and expand the new federal Testing Assistance Response Team to meet surge capacity needs, including in remote and isolated communities. Government-Wide Priority: Keeping Canadians Safe and Healthy |
| Facilitated access to health products | Core Responsibility 2: Health Protection and Promotion |
Government-Wide Priority: As above |
| Provided timely, trusted and evidence-based information | Core Responsibility 2: Health Protection and Promotion Internal Services |
Mandate Letter Commitment: Support openness, effectiveness and transparency in government. Improve digital capacity and services for Canadians. Government-Wide Priority: As above |
| Enhanced internal services | Internal Services | Mandate Letter Commitment: Ensure a safe, respectful, rewarding and welcoming place of work. Government-Wide Priority: Commit to implementing Government plans aimed at protecting and supporting Canadians through challenging times. |
Delivering on its mandate to ensure Canadians stay safe and healthy during a pandemic
Health Canada used every tool available, leveraged resources and collaborated with F/P/T partners to protect the health of Canadians. The Department sustained a high-level of activity to respond to and mitigate risks associated with the pandemic while continuing to deliver on its mandate in 2021-22.
Key examples of Health Canada's risk responses:
Fostered engagement and collaboration
- Worked alongside the Public Health Agency of Canada and the Chief Public Health Officer via the COVID-19 Task Force to advance a whole-of-government approach by engaging and collaborating with partners and stakeholders to adapt to, and meet, the needs of Canadians. For example:
- Provided testing guidance and financial support to PT/s through the Safe Restart Agreement, including health human resources and other surge supports to healthcare systems under stress; supported testing and wastewater surveillance research and infrastructure; as well as supported strengthening data management for P/Ts and Indigenous organizations.
- Worked collaboratively with P/Ts to ensure optimal accessibility of the 402 million rapid tests distributed to Canadians.
- Exchanged knowledge and best practices across jurisdictions through various forums such as the Industry Round Table and the Knowledge Exchange.
- Led and supported multiple COVID-related intergovernmental and external advisory committees including the Variants of Concern Leadership Group and the Federal Pandemic Science Coordination and Action Group.
- Under the Safe Restart Agreement Contribution Program, funded:
- The Creative Destruction Lab Rapid Screening Consortium for $8.98 million that on-boarded nearly 2,000 organizations to put in place workplace-screening programs. It resulted in 3,497 operational screening sites across Canadian. This led to the administration of over 2.3 million rapid antigen tests.
- The Canadian Chambers of Commerce for $8.52 million to set up a network with local chambers to distribute 7.574 million rapid antigen tests to small and medium-sized enterprises with under 200 employees in 6 provinces (ON, QC, NS, NB, SK, and AB) to support economic re-opening.
- The Canadian Red Cross for $6.63 million to ensure that rapid tests were distributed to non-profits and charities to help workers, volunteer, and individuals in vulnerable groups, resulting in the distribution of 1.2 million tests throughout Canada.
- Together with Public Services and Procurement Canada, worked with P/Ts, as well as Canadian pharmaceutical companies, to build the Critical Drug Reserve, a back-up inventory of 12 key drugs used in the treatment of COVID-19 patients.
- Provided expert advice on Good Manufacturing Practices (GMP) to increase domestic biomanufacturing capacity, including specialized advice and guidance to meet the unique needs of pharmaceutical companies developing or entering the Canadian biomanufacturing market.
- Supported P/Ts, including with health system surge capacity through the sourcing of health human resources, for example:
- Worked closely with Public Safety Canada to establish the Humanitarian Workforce program as an essential surge support tool for P/Ts, including the sourcing of health human resources to support hospital capacity and COVID-19 vaccination programs.
- Worked in partnership with federal partners, PHAC, Public Safety Canada, P/Ts and the Canadian Red Cross to provide surge capacity for such competencies as contact tracing, nursing, and outbreak management, including in northern, remote, and isolated communities.
- Collaborated with Public Safety Canada and Public Services and Procurement Canada to deploy two federal Mobile Health Units in Ontario resulting in the provision of 200 additional hospital beds and the transfer of non-critical care patients out of the ICU to ensure more effective use of specialized resources.
- Worked with PHAC to monitor the safety and effectiveness of COVID-19 vaccines and other products and to rapidly investigate and mitigate any risks.
- Supported international efforts to ensure access to health interventions to fight COVID-19.
Facilitated access to health products
Established and maintained innovative and agile measures, including prioritizing and expediting the regulatory review of COVID-related products without compromising standards for safety, efficacy and quality. For example:
- Remade or made permanent regulations to expedite the review of medical devices, drugs and clinical trials; allowed exceptional importation of drugs, medical devices and foods for a special dietary purpose; and, provided additional tools to help prevent and alleviate shortages of drugs and medical devices that may have been caused or worsened by the pandemic.
- Engaged with F/P/T partners, industry, international partners and healthcare professionals to facilitate access to drugs and devices for the diagnosis and treatment of COVID-19.
- Established a time-limited (May 2020-June 2022), cost-shared COVID-19 Critical Drug Reserve with P/Ts to mitigate shortages of 12 critical COVID-19 drugs.
- Supported businesses that were ready to mobilize needed products, and provided guidance and advice on regulatory requirements.
- Maintained and updated the Department's COVID-19 web portal for Canadians, health professionals and academics with regulatory information on vaccines and treatments for COVID-19; including an industry-specific site with up-to-date information on health products.
- Monitored the safety and effectiveness of COVID-19 drugs, vaccines and treatments.
- Prioritized pesticide applications to focus on the highest priorities and offered flexibilities to registrants to facilitate the manufacturing of sanitizers and disinfectants or concentrates to help address shortages and meet product demand.
Provided timely, trusted and evidence-based information
- Provided Canadians and health care providers with the timely, clear, trusted, accessible, and evidence-based information they needed to protect themselves, and their families, communities and businesses. For example:
- Used various communication channels to provide the latest information on vaccine authorizations, safety and efficacy to increase vaccine confidence and encourage uptake.
- Expanded and published 4000+ COVID-19-related web pages on Canada.ca/coronavirus to enable Canadians to access all federal COVID-19 related information, including vaccination, testing, and programs from a single site.
- Provided Canadians and healthcare providers with guidance and scientific evidence-based information through the COVID-19 Testing and Screening Expert Advisory Panel reports on borders and on self-testing, a report on Testing for COVID-19 in vaccinated populations and through updates to the Pan-Canadian Guidance on Testing and Screening.
Enhanced internal services
- Delivered critical services and commitments during a major health crisis, by focusing on key activities such as:
- Partnered with Shared Services Canada to upgrade network infrastructure to stabilize and support modern tools for business needs.
- Ensured departmental resources had reliable, responsive and secure network access by doubling the Virtual Private Network and internet bandwidth capacity to support 20,000 concurrent users.
- Identified global threats through enhanced cyber security practices, conducted 273 security assessments, and reminded employees of the importance of protecting information while working remotely.
- Reviewed over 47 customized digital solutions to ensure that the Department provided Canadians with accessible services.
- Provisioned devices, accounts, licences and product support to facilitate remote as well as maintained physical distancing, and ensured a healthy and safe workplace through access to on-site personal protective equipment and enhanced cleaning protocols.
- Leveraged existing Business Continuity Management plan practices to promote the consideration of potential impacts from major health events like COVID-19.
| Risk Responses | Link to the Department's Core Responsibilities | Link to Mandate Letter Commitments or Government-Wide Priorities |
|---|---|---|
| Implemented new policies | Core Responsibility 1: Health Care Systems |
Mandate letter commitment: Continue to ensure compliance with the CHA on matters of private delivery and extra billing. Government priority: Keeping Canadians Safe and Healthy |
| Worked to resolve issues with P/Ts | As above | Mandate letter commitment: Continue to ensure compliance with the CHA on matters of private delivery and extra billing Government priority: Keeping Canadians Safe and Healthy |
| Monitored litigation | As above | As above |
| Monitored changes in health care delivery | As above | Mandate letter commitment: Work with P/Ts to ensure that all Canadians have access to appropriate a primary health care team and expand virtual health care, critical health and mental health resources and services. Government priority: As above |
Uphold the Canada Health Act
Health Canada upholds the Canada Health Act (CHA) in an ever-changing environment. The Department's proactive responses have mitigated the risks associated with the CHA during the 2021-22 fiscal year.
Key examples of Health Canada's risk responses:
Implemented new policies
- Worked with P/Ts to ensure compliance with the Diagnostic Services Policy. Due to the retrospective nature of CHA reporting, P/Ts are to first report on compliance with the Policy in December 2022.
Worked to resolve issues with P/Ts
- Evaluated provincial and territorial Reimbursement Action Plans to eliminate patient charges. For example:
- Worked with British Columbia and Newfoundland and Labrador on their respective Plans, which resulted in British Columbia receiving a partial reimbursement for actions taken to reduce the incidence of patient charges in that province and in Newfoundland and Labrador being fully reimbursed for successfully eliminating patient charges in that jurisdiction. Initiated a Reimbursement Action Plan with Ontario to address patient charges occurring in that province.
Monitored litigation
- Monitored litigation that may implicate the CHA and supported federal involvement as required. For example:
- Monitored the case brought by the Canadian Civil Liberties Association in New Brunswick, which alleges the province's policies on coverage for abortion services contravened the CHA.
- Continued to support British Columbia during the appeal stage of the Cambie Charter challenge, which concluded on July 15, 2022 with a dismissal of the appeal. The plaintiffs sought to strike down provisions in the British Columbia's health insurance legislation that mirror those in the Canada Health Act.
Monitored changes in health care delivery
- Monitored changes in health care delivery for their effects on access to insured service. For example:
- Monitored and assessed virtual access to primary health care services, which expanded rapidly in Canada in response to the COVID-19 pandemic.
- Researched and analyzed issues such as: home care; access to sexual and reproductive health services; impacts of health care systems modernization on the health workforce; quality of care; health care systems and service delivery innovation; and health technology.
Key Risks for Core Responsibility 2: Health Protection and Promotion
| Risk Responses | Link to the Department's Core Responsibilities | Link to Mandate Letter Commitments or Government-Wide Priorities |
|---|---|---|
| Implemented informative initiatives | Core Responsibility 2: Health Protection and Promotion |
Government priority: Keeping Canadians Safe and Healthy |
| Provided more engagement opportunities with Canadians and stakeholders | As above | As above |
| Improved communication tools | As above | As above |
Maintain confidence in Health Canada as a trusted regulator
To ensure that Health Canada continues to be seen as a trusted regulator and credible source of information, and to help Canadians make informed health and safety decisions, the Department successfully implemented effective risk responses in the 2021-22 fiscal year.
Key examples of Health Canada's risk responses:
Implemented informative initiatives
- Expanded the amount of regulatory health and safety information made available to Canadians in a simple and accessible way through innovative initiatives and communication activities. For example:
- Provided and published information and products such as guidance, tables and reports related to priority COVID test technologies, accessibility and environmental sustainability, non-compliant marketing related to COVID-19, and quarterly and annual surveillance reports on health and safety incidents related to consumer products and cosmetics in Canada. Such products are considered a priority and serve an urgent public health need.
- Published Adverse reactions to health products – annual report 2020 in the September 2021 InfoWatch newsletter on the MedEffect Canada web page.
- Published compliance monitoring reports on drugs, natural health products and medical devices to keep Canadians informed of compliance monitoring efforts. Where compliance issues were identified, the Department took the necessary actions to protect the health and safety of the people in Canada.
- Continued to promote awareness through several campaigns such as the Healthy Home Campaign, safety of radiofrequency electromagnetic fields and 5G technology, and Consider the Consequences of Vaping.
Provided more engagement opportunities to Canadians and stakeholders
- In line with the Government of Canada's Open Government initiative and Health Canada's Forward Regulatory Plan, Canadians and stakeholders had greater opportunity to be involved in decision-making processes, including the regulatory process throughout its development. For example:
- Consulted Health Canada's Scientific Advisory Committee, medical device stakeholders and regulatory representatives to support regulatory agility and communication regarding medical devices, improve safety and effectiveness and to seek timely patient-centered, scientific, technical, medical and clinical advice regarding women's health and the regulation of medical devices and drugs.
- Consulted stakeholders from various sectors including federal partners, key industry, academia, and health and advocacy associations to publish proposed regulations, amendments and initiatives related to foods such as regulations on Supplemented Foods and front-of-package nutrition labelling in the Canada Gazette, Part I, Clinical Trials Regulatory Modernization Initiative for special dietary foods, proposal for the modification of two marketing authorizations to allow safe uses of certain food enzymes and preservatives in human milk fortifiers.
- Consulted on two proposals to update the maximum level for total arsenic in fruit juice and fruit nectar, and to add a maximum level for inorganic arsenic in rice-based foods for infants and young children.
- Published 75 new datasets from Canada's Total Diet Study and other targeted surveillance data on contaminants in food to the Government of Canada's Open Data Portal and to Public CANLINE.
- Consulted with Canadians and stakeholders on a variety of proposed amendments and regulations, including topics such as lasers, the Cosmetic Ingredient Hotlist, Cosmetic Regulations, Surface Coating Materials Regulationsand theTent Regulations.
- Consulted stakeholders on supply chain transparency and labelling of chemicals in consumer products and held discussions on options for addressing the consumer products exclusion in the Hazardous Products Act. Initiated the development of chemical classification decision trees for hazardous products used, stored or handled in the workplace
- Consulted and sought feedback from Canadians through numerous cannabis public consultations including the proposed Regulations Amending the Cannabis Regulations (Flavours in Cannabis Extracts), Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages, and Guidance on Personal Production of Cannabis for Medical Purposes, which set out proposed factors Health Canada may consider in refusing or revoking a registration on public health and public safety grounds. A What We Heard report and the final guidance were published in April 2022.
- Established an Expert Task Force on Substance Use to provide Health Canada with independent, expert advice and recommendations on the federal government's drug policy and potential alternatives to criminal penalties for the simple possession of controlled substances. The Task Force reports are available on the HC External Advisory Body website.
Improved communication tools
- Continued to acquire, develop and improve the tools, processes and resources needed to effectively communicate to, and engage, Canadians on Health Canada's digital platforms, including Canada.ca and Health Canada social media channels. For example:
- Released valuable COVID-19-related data and information to inform the public while employing digital tools to improve the reach of and dissemination of information.
- Collaborated with federal partners to innovate, leverage and/or optimize content and digital tools for Canadians and streamline and automate the publishing of data to Canada.ca allowing internal stakeholders to manage publishing and update in real time.
- Implemented a new, user-focused recalls and safety alerts system that will improve the ability of Canadians to take action to protect themselves from unsafe products.
- Promoted and amplified reports from the COVID-19 Exposure Notification App Advisory Council.
- Supported Canadian Centre for Substance Use and Addiction's update of the Canadian Low-Risk Drinking Guidelines to reflect the latest scientific evidence on alcohol-related risks and harms.
| Risk Response | Link to the Department's Core Responsibilities | Link to Mandate Letter Commitments or Government-Wide Priorities |
|---|---|---|
| Strengthened oversight | Core Responsibility 2: Health Protection and Promotion |
Mandate letter commitment: Safe and sustainable use of effective pesticide products in Canada. Government priority: Keeping Canadians Safe and Healthy |
| Collaborated internationally | As above | Government priority: As above |
| Increased regulatory and non-regulatory activities | As above | Government priority: As above |
Protect Canadians from the risks of products
To help protect Canadians from the risks of products in an innovative and globalized environment, the Department successfully implemented risk responses to alleviate the risk.
Key examples of Health Canada's risk responses:
Strengthened oversight
- Developed strategies and tools to strengthen market surveillance and oversight of emerging products. For example:
- Inspected 36 vaping manufacturers to verify industry compliance with requirements related to packaging/labelling, promotions, nicotine concentration, and child-resistant containers.
- Conducted 56 project-based inspections of new and emerging cannabis products (e.g. cannabis extracts, edible cannabis, and cannabis vaping products) and analyzed 325 cannabis product samples for potential presence of allergens, cannabinoid content, microbial and chemical contaminants and ethanol. 98% of the cannabis product samples analyzed were found to be satisfactory with the applicable legislative and regulatory requirements.
- Used an Artificial Intelligence platform to proactively monitor drugs and devices that made illegal, false, or misleading claims of preventing, treating, or curing COVID-19 or Cancer. The strengthened approach reduces the risk of Canadians being exposed to false and misleading advertising, which may pose a risk to their health and safety.
Collaborated internationally
- Collaborated with international regulatory organizations, and aligned where appropriate with foreign regulators. For example:
- Engaged with international regulatory partners on COVID-19 vaccines and treatments through representation and frequent leadership in a variety of fora such as the regulatory cluster meetings between the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada; International Coalition of Medicines Regulatory Authorities (ICMRA) COVID-19 consultations; and, the Committee for Medicinal Products for Human Use regulatory consultations.
- Supported the development of international guidance on COVID-19 vaccines via ACCESS and World Health Organization (WHO) as well as amendments to guidance in other agencies. Involvement with the EMA, FDA and ICMRA consultative regulatory processes has resulted in more informed decisions, harmonized product specifications, and enhanced pharmacovigilance, all of which has improved regulatory oversight of these products.
- Worked with international partners on COVID-19 issues, including clinical trials, product market authorizations, risk assessments and product shortages. For example, worked with European Medicines Agency to assess the process for COVID-19-related medicinal products, including vaccines.
- Strengthened relationships with international regulators through information sharing on various post-market surveillance activities such as safety issues, inspections, recalls, and shortages. This enhanced trust, confidence, cooperation and collaboration with international partners on issues of mutual priority. For example, communicated 233 consumer product recalls, including 59 joint recalls with the United States and/or Mexico, regarding unsafe consumer products and cosmetics.
- Shared with the European Commission industry and product information and the corrective actions taken on consumer products and cosmetics that may present a risk to Canadians.
- Co-chaired two working groups of the International Medical Device Regulators Forum on cybersecurity, and the development of a dynamic template to support the electronic transmission of regulatory submissions and chaired the Medical Device Single Audit Program, which allowed a single regulatory audit to satisfy the regulatory requirements of multiple jurisdictions by aligning technical requirements and reducing regulatory burden without compromising public health.
- Chaired an international drug shortages working group that included representatives from the United States, United Kingdom, EMA, Australia, Japan and WHO.
- Published a joint statement with the United States Food and Drug Administration and the United Kingdom's Medicines and Healthcare products Regulatory Agency on Guiding Principles for Good Machine Learning Practices for medical device development.
- Continued to exchange information with the European Medicines Agency-Committee for Medicinal Products for Human Use on non-COVID products as part of Health Canada's Committee for Medicinal Products for Human Use observership.
- Continued Health Canada's role as an advisor to the work of the Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – Innovative Medicines Initiative Consortium.
- Promoted the global implementation and adoption of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) through active participation in the United Nations Sub-Committee of Experts on the GHS.
- Were designated as a World Health Organization Collaborating Centre on Environmental Health for 4 years (2021-2025). This designation will facilitate international collaboration on managing the health effects of environmental risk factors such as air pollution, drinking water quality, chemical exposures and climate change.
- Hosted the 5th North America Consumer Product Safety Summit in September 2021, which brought together North American product safety regulators, as well as industry stakeholders and other interested parties from across North America and internationally.
Increased regulatory and non-regulatory activities
- Increased regulatory and non-regulatory activities to address changing business models in the supply chain, specifically as they relates to inspecting foreign manufacturing sites. For example:
- Exchanged Good Manufacturing Practices (GMP) information with trusted regulators through Mutual Recognition Agreements with the European Union, Switzerland, Australia and the United Kingdom.
- Participated as a member of the International Coalition of Medicines Regulatory Authorities to advance global databases for sharing inspection-related information and compliance and enforcement actions.
- Appointed chair of the Pharmaceutical Inspection Co-operation Scheme, allowing Canada to take a leadership role in advancing inspection reliance and harmonizing inspection approaches.
- Shared information on proven or promising regulatory and non-regulatory measures to address antimicrobial resistance (AMR). For example:
- Championed the launch of ICMRA's Best Practices project which will share information to address AMR.
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