Health Canada’s regulatory response to COVID-19: Access to health products
On this page
- Medical devices
- Testing devices
- Personal protective equipment
- Hand sanitizers and disinfectants
- Drugs and vaccines
- Addressing critical product shortages
- Post-market surveillance activities
- Engaging with partners and stakeholders
- Moving forward
One of Health Canada's roles is to regulate and authorize health products that improve and maintain the health and well-being of Canadians.
The COVID-19 pandemic has created an unprecedented demand on Canada's health care system and has led to an urgent need for access to health products.
As part of the government's broad response to the pandemic, Health Canada introduced innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards.
These measures are helping to make health products and medical supplies needed for COVID-19 available to Canadians and health care workers. Products include:
- testing devices, such as test kits and swabs
- personal protective equipment (PPE) for medical purposes, such as medical masks, N95 respirators, gowns and gloves
- disinfectants and hand sanitizers
- investigational drugs and vaccines
We support the safe and timely access to these critical products through:
- temporary legislative, regulatory and policy measures
- partnerships and networks with companies, provinces and territories, other government departments, international regulatory bodies and health care professionals
- easily accessed and available guidance and other priority information
We have also taken immediate steps to protect consumers from unauthorized health products and illegal, false or misleading product advertisements that claim to mitigate, prevent, treat, diagnose or cure COVID-19.
Medical devices play an important role in diagnosing, treating, mitigating or preventing COVID-19.
We are expediting access to medical devices through an interim order for importing and selling medical devices. A first interim order (IO) was introduced to that effect on March 18, 2020. A second, similar IO was introduced on March 1, 2021. On February 21, 2022, Interim Order No. 3 respecting the importation and sale of medical devices for use in relation to COVID-19 replaced Interim Order No. 2. This IO maintains the flexibilities and regulatory oversight of the second IO so that devices can continue to be sold and imported into Canada. All three IOs cover medical devices such as:
- testing devices
- personal protective equipment (PPE)
- sterilizers and decontamination devices
Since the release of the interim order, we have authorized hundreds of medical devices for use against COVID-19.
We have also expedited the review and issuance of thousands of Medical Device Establishment Licences (MDELs). These have been issued for companies asking to manufacture (Class I), import or distribute medical devices in relation to COVID-19.
Early diagnosis is critical to slowing and reducing the spread of COVID-19 in Canada. Our initial focus during the pandemic has been the scientific review and authorization of testing devices.
We made it a priority to review diagnostic tests using nucleic acid technology. This helped to increase the number of testing devices available in Canada to diagnose active and early-stage infections of COVID-19.
We are also reviewing and authorizing serological tests that detect previous exposure to COVID-19. In May 2020, we authorized the first serological testing device to help improve our understanding of the immune status of people infected. We also provided guidance on serological tests.
We continue to collaborate with the Public Health Agency of Canada's National Microbiology Laboratory (NML) and with provincial public health and laboratory partners as they:
- review and engage in their own studies of serological technologies
- develop tests
- assess commercial tests
The NML is known around the world for its scientific evidence. It works with public health partners to prevent the spread of infectious diseases. When making regulatory decisions, we consider the data provided by the NML and provincial public health and laboratory partners.
This work will facilitate access to devices that will improve our testing capacity. It will also support research into understanding immunity against COVID-19 and the possibility of re-infection.
Personal protective equipment
Personal protective equipment (PPE) is key to protecting health care workers, patients and Canadians through infection prevention and control.
We play an important role in providing guidance to companies and manufacturers in Canada that want to supply PPE. We are increasing the range of products available without compromising safety and effectiveness. For example, we are:
- fast-tracking the scientific review of PPE for medical purposes, where appropriate
- supporting new companies making PPE
- includes providing information for 3D-printing PPE to support innovative manufacturing approaches
- providing guidance on medical gloves, medical gowns and medical masks and respirators
- providing guidance on the use of acceptable alternative products to medical-grade PPE to assist with supply needs, such as:
- using expired medical gowns
- reprocessing and decontamination of N95 respirators
- optimizing the use of medical masks and respirators during COVID-19
- allowing temporary regulatory agility by accepting internationally recognized specifications for PPE
We have authorized hundreds of new PPE products and other devices, all while ensuring the safety and quality of PPE.
Hand sanitizers and disinfectants
The COVID-19 pandemic created an urgent need for disinfectants and hand sanitizers. To increase supply and ensure Canadians have access to these products, we:
- published an interim step-by-step guide to obtaining a licence to manufacture and sell alcohol-based hand sanitizer, an interim guide on the production of ethanol and an interim guide on the production of isopropyl alcohol for this purpose
- as a result, companies that were not previously producing health products have adapted to support the supply needs for hand sanitizers
- expedited the review of hand sanitizers and disinfectants, and provided information on our approach
- made it a priority to review disinfectants with COVID-19-related claims
- set out specific requirements for using other sources of ethanol to produce hand sanitizers to meet the supply shortage, based on thorough scientific review
- helped to match suppliers of raw materials with manufacturers of hand sanitizers through the Hand Sanitizers Manufacturing Exchange
- put in place exceptional measures to:
We will continue our efforts to support supply and access to these essential products.
Drugs and vaccines
Drugs and vaccines play an essential role in the ability of Canadians to recover safely from the COVID-19 pandemic. There are many potential products being investigated in Canada and around the world for use against COVID-19. We are closely tracking all potential drugs and vaccines in development.
We are working closely with stakeholders and have put in place measures to help expedite the review and authorization of drugs and vaccines. These measures uphold Canada's high standards for safety, efficacy and quality.
On December 9, 2020, we authorized the first vaccine in Canada for the prevention of COVID-19.
Find out about COVID-19 vaccines that are authorized in Canada.
You can search the complete list of drugs and vaccines that have been authorized for treating and preventing COVID-19.
The new Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations), published in the Canada Gazette II on March 2, 2022, came into effect on February 27, 2022, following the repeal of Interim Order No. 2.
The Regulations are a temporary measure. They will maintain the flexibilities and pathway set out by the interim order until the framework established through the Clinical Trials Modernization Initiative is in place. By reducing administrative burden, the Regulations will continue to:
- facilitate the authorization and implementation of COVID-19-related clinical trials
- uphold the health and safety requirements for trial participants and validity of trial data
For more information on how to apply for clinical trials under the Regulations, see the following guidance documents:
- Guidance on applications for COVID-19 drug clinical trials under the Regulations
- Guidance on applications for COVID-19 medical device clinical trials under the Regulations
As well, to encourage the rapid development of drugs and vaccines, we are:
- prioritizing COVID-19 clinical trial applications
- providing regulatory agility and guidance on how clinical trials are to be conducted
- working with companies outside of Canada to bring clinical trials to our country
- working with researchers around the world to add Canadian sites to their research efforts
This encourages and supports the launch of new trials and the continuation of existing ones, as well as broader patient participation across the country.
On May 15, 2020, we authorized Canada's first vaccine clinical trial.
Drug and vaccine authorization
Health Canada reviews scientific evidence of a drug or vaccine, including results from clinical trials, to assess the product's safety, efficacy and quality before it can be sold in Canada. To facilitate earlier access to COVID-19 drugs or vaccines, Health Canada prioritized the review of these products while ensuring there is adequate evidence of safety, efficacy and quality to merit access to Canadians.
On September 16, 2020, the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO) introduced a temporary regulatory pathway. This helped expedite authorizations for COVID-19-related drugs and vaccines without compromising patient safety.
The ISAD IO created a more agile pathway to facilitate the availability of COVID-19-related drugs and vaccines for Canadians in 4 ways:
- authorizing a brand new drug based on available evidence with more agile administrative and application requirements
- authorizing a new drug based on the approval of a trusted foreign regulatory authority
- allowing expanded use of an already approved drug to include COVID-19-related indications based on known evidence with or without an application from the market authorization holder
- permitting the Public Health Agency of Canada to import promising COVID-19 drugs for placement (pre-positioning) in Canadian facilities before they are authorized in Canada
As of October 2020, Health Canada began receiving submissions for approval under the ISAD IO. The data provided in a submission is carefully reviewed to ensure that any new vaccine or treatment made available to Canadians is safe, effective and of high quality.
The ISAD IO expired on September 16, 2021. To ensure that COVID-19-related drugs authorized under the ISAD IO may continue to be imported and sold in Canada, we introduced transition measures to amend the Food and Drug Regulations. The amendments ensure that the review, authorization and oversight of COVID-19 drugs, including new drugs, can now be conducted under the Regulations.
Learn more about drug and vaccine authorizations for COVID-19.
Special Access Program
The Special Access Program (SAP) is for health care professionals who are treating seriously ill patients where conventional therapies have failed, are unsuitable or are unavailable. We recently modernized the regulations for the SAP to better facilitate access to drugs for Canadians, including treatments for COVID-19. These regulatory changes make it easier for practitioners to request certain drugs without submitting data on the use, safety and efficacy of a drug previously authorized through the SAP. The changes also mean consideration will be given to:
- drug companies wishing to import a drug into a Canadian facility, in anticipation of it being requested by a practitioner and
- allowing drugs authorized through the SAP to be shipped to community pharmacies
Addressing critical product shortages
the COVID-19 pandemic has had an impact on the supply of critical products in Canada. Health Canada continues to actively monitor for vulnerabilities in Canada's supply chain and work to mitigate them to help prevent or alleviate shortages.
Early in our pandemic response, we also introduced interim regulatory measures to address drug shortages.
On March 30, 2020, we introduced an interim order to prevent or ease shortages of drugs, medical devices and foods for a special dietary purpose. We extended that initial measure from March 31, 2021, until March 1, 2022. We also published new amendments to the Food and Drug Regulations in Canada Gazette, Part II on September 1, 2021. This created a permanent pathway for the exceptional importation and sale of foreign-authorized drugs and medical devices into Canada in response to a shortage. It also created a shortage reporting framework for certain medical devices. These Regulations entered into force on March 2, 2022.
Health Canada works with provinces and territories, companies and manufacturers, health care providers and patient groups to strengthen the drug supply chain.
To identify, prevent and ease shortages for Canadians, we:
- stepped up monitoring and surveillance activities to identify potential shortages early on
- introduced temporary regulatory agility so manufacturers can ramp up production
- for example, increased the batch sizes
- regularly engaged stakeholders to share information and look at how we can prevent Tier 3 drug shortages, which have the greatest impact on Canada's drug supply and health care system
- helped to access extra supplies of:
- drugs, including muscle relaxants, inhalers and sedatives
- medical devices, such as PPE (medical masks and gowns) and ventilators
Post-market surveillance activities
We actively monitor the post-market safety and effectiveness of health products related to COVID-19. For example, we work with industry members and health care workers to:
- monitor safety issues
- take the necessary steps to protect Canadians from the effects of harmful products
To ensure the ongoing safety of marketed health products, we:
- take proactive steps to identify COVID-19-related adverse events from drugs and medical devices being used in Canada for COVID-19
- proactively monitor major online retailers to identify authorized/unauthorized products making false and misleading COVID-19 claims
- manage risk communications for COVID-19 public advisories, information updates, health care professional communications and shortages
- take a proactive approach to identifying false and misleading ads for health products related to COVID-19
- take part in international discussions on the real-world safety and effectiveness of COVID-19 treatments
Engaging with partners and stakeholders
To support access to health products for COVID-19, we collaborate with a range of organizations and stakeholders. These include other government departments, including the Public Health Agency of Canada, as well as provinces and territories, international partners, companies and health care professionals.
Engaging with stakeholders
We take a whole-of-government approach to address stakeholder issues by:
- collaborating with other government departments to ease challenges across the entire supply chain
- connecting companies with government decision makers who play important roles in delivering health products to Canadians
These efforts create opportunities for new companies and researchers interested in helping in the fight against COVID-19. For example, we have worked with other departments to help new companies supply PPE to Canadians and health care workers. Some of these companies had only ever manufactured auto parts, clothing and sports equipment before the pandemic.
We engage the health products sector in mobilizing to find COVID-19 solutions by:
- meeting with industry leaders to identify and track potential health products
- ensuring that the regulatory review of promising health products is done in a timely manner
- hosting information sessions on our regulatory response
- maintaining a centralized COVID-19 website with relevant information for industry and health professionals
Engaging with domestic partners
We work closely with provincial/territorial public health partners and health system partners. For example, we:
- share information with our provincial/territorial health partners about regulatory guidance for reprocessing N95 respirators for health professionals
- continue to engage and share information with our health system partners, such as health technology assessment agencies, to support efficiencies and alignment
- inform health professional networks of our activities and seek their perspectives on health care system priorities and challenges
Engaging with international partners
We are working with our international partners on a coordinated and well-aligned approach to this global pandemic. This ensures that health products are effective and quickly available to Canadians. Collaboration also helps advance the development of diagnostics, treatments and vaccines that will save lives and protect the health and safety of people everywhere.
Specifically, our international engagement 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
Notably, we are participating in the:
- International Coalition for Medicines Regulatory Authorities as an executive committee member and playing a leadership role in helping to align policy approaches and regulatory agility in response to the COVID-19 pandemic
- World Health Organization's research and development (R&D) blueprint vaccines plan to develop a COVID-19 vaccine
- Pan American Health Organization as a member of its COVID-19 task group
Looking ahead, we will build on the temporary regulatory agilities put into place to inform future agile approaches to regulation that support innovation and safety. We will communicate with stakeholders before shifting away from these temporary measures.
We will also continue to work with our partners to:
- provide products and information that Canadians need to keep safe and healthy
- respond to emerging priority areas, anticipate needs and regularly review our policy and regulatory priorities
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