Health Canada’s regulatory response to COVID-19: Access to health products

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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:

We support the safe and timely access to these critical products through:

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

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. This second IO maintains the flexibilities and regulatory oversight of the first IO until at least fall 2021 so that devices can continue to be sold and imported into Canada. Both IOs cover medical devices such as:

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.

Testing devices

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:

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:

We have authorized hundreds of new PPE products and other devices, all while ensuring the safety and quality of PPE.

Hand sanitizers, disinfectants, cleaners and soaps

The COVID-19 pandemic created an urgent need for disinfectants, hand sanitizers, cleaners and soaps. To increase supply and ensure Canadians have access to these products, we:

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.

Clinical trials

On May 3, 2021, the Minister of Health signed a second interim order (IO) for clinical trials for medical devices and drugs related to COVID-19. This new IO replaces the original signed on May 23, 2020, and continues to support the optional pathway to facilitate clinical trials for potential COVID-19 drugs and medical devices.

This temporary measure is designed to meet the urgent need to diagnose, treat, reduce or prevent COVID-19. The interim order facilitates clinical trials in Canada to investigate and offer greater patient access to potential COVID-19 drugs and medical devices, while upholding strong patient safety requirements.

As well, to encourage the rapid development of drugs and vaccines, we are:

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 Minister of Health signed an interim order (ISAD IO) that introduced a temporary regulatory pathway. This helped expedite authorizations for COVID-19-related drugs and vaccines without compromising patient safety.

The interim order created a more agile pathway to facilitate the availability of COVID-19-related drugs and vaccines for Canadians in 4 ways:

  1. authorizing a brand new drug based on available evidence with more agile administrative and application requirements
  2. authorizing a new drug based on the approval of a trusted foreign regulatory authority
  3. 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
  4. 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:

Addressing critical product shortages

We are actively monitoring the impact of the COVID-19 pandemic on the supply of critical products in Canada. This includes identifying areas in Canada's supply chain where supply may be vulnerable and addressing those vulnerabilities before shortages develop.

Health Canada has also introduced regulatory measures to address drug shortages.

One of these measures was an interim order to prevent or ease shortages of drugs, medical devices and foods for a special dietary purpose It was originally introduced on March 30, 2020. A second, similar IO was introduced on March 1, 2021. It extends and modifies certain measures already in place to prevent or alleviate shortages of key products in Canada. This IO temporarily:

As well, on September 18, 2020, the Minister of Health approved an interim order on preventing and alleviating drug shortages in relation to COVID-19. This IO provides more tools to urgently address drug shortages related to COVID-19 by authorizing the Minister of Health to:

We also work 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:

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:

To ensure the ongoing safety of marketed health products, we:

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:

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:

Engaging with domestic partners

We work closely with provincial/territorial public health partners and health system partners. For example, we:

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:

Notably, we are participating in the:

Moving forward

Looking ahead, we will build on the temporary regulatory agilities we put into place to inform future agile approaches to regulation that support innovation and safety.

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:

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