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Health Canada and the Public Health Agency of Canada’s report on red tape reduction

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Executive summary

Health Canada and the Public Health Agency of Canada are jointly responsible for protecting the health and safety of people in Canada. Regulations are an important tool in fulfilling this mandate. For example, they protect the safety and quality of food, medications and other consumer products that may have an impact on health and safety of people in Canada. However, regulations can be complex, overly prescriptive or become outdated, which can result in administrative burden or “red tape”. Rules, processes and regulations can place burden on individuals, businesses, organizations or government administrators without delivering added benefit to public health and safety.

Stakeholders have also raised a number of concerns about red tape in recent years. These include issues such as duplicate requirements, complex forms and processes, and lengthy approval processes. The impact of these issues can range from minor administrative irritants to larger regulatory barriers, which could undermine the government’s or health sector's ability to address health and safety risks.

Recognizing both the need to modernize regulatory frameworks and support robust economic growth in Canada, the Government of Canada launched a Red Tape Review across all federal departments and agencies in July 2025.

This review is important given the increasingly rapid pace of global innovation, the complexity of supply chains for key health products and the threats posed to the international flow of critical goods. The government aims to have regulatory programs that are as strong, modern, flexible and effective as possible. Health Canada and the Public Health Agency of Canada view the current context as an opportunity to respond to stakeholder concerns and to continue to chart a path towards a more agile and responsive regulatory system.

The Red Tape Review builds upon work already completed in recent years to modernize regulations. However, Health Canada and the Public Health Agency of Canada acknowledges that additional work can be done to further streamline rules and reduce burden on both regulated parties and the government.

The department and the agency aim to create a regulatory system that is calibrated to risk, built on cooperation with like-minded regulators around the world, encourages a strong Canadian industry and improves the user experience.

This report presents the initiatives and actions that have been identified to remove regulatory red tape, without undermining the core purpose of regulations to protect health and safety. These initiatives are organized into 5 themes:

  1. International alignment and reduction of trade barriers

    Health Canada regulates products that are sold globally with different international requirements. This can create trade barriers, slow innovation and limit access to the Canadian market. Stakeholders have also requested greater alignment with trusted foreign regulators.

    Health Canada and the Public Health Agency of Canada are responding with initiatives that increase joint activities with other jurisdictions. For example Health Canada is expanding joint reviews for pest control products with our international regulatory partners, such as the United States, European Union, United Kingdom, Australia and New Zealand. Health Canada is also increasing the use of regulatory reliance, international cooperation and mutual recognition agreements which will allow us to use and rely on information and decisions from trusted international partners.

    Such initiatives aim to reduce duplication, ease the burden on industry and support economic growth while maintaining high safety standards.

  2. Improving client experience and service delivery

    Stakeholders have raised concerns about the need to navigate complex regulatory requirements. They have also indicated the need for clearer guidance and better communication.

    In response, Health Canada and the Public Health Agency of Canada are advancing initiatives that simplify processes, enhance transparency, provide guidance and training, and fast-track regulatory decisions through digital platforms and more effective service delivery. For example, Health Canada delayed labelling requirements for natural health products after concerns were raised about the implementation challenges for small packaging. The department is planning to:

    • support the use of electronic labels for pest control products
    • reduce information requirements for certain cannabis applications
    • improve timeliness of drug approvals
    • facilitate training for regulated parties working with pathogens and toxins and
    • streamline inspections for companies with multiple product lines

    This will reduce burden while maintaining regulatory oversight.

  3. Risk-based regulating

    Traditionally, some regulatory approaches have treated low- and high-risk products the same. Applying the same level of oversight has created unnecessary burdens. Health Canada and the Public Health Agency of Canada are shifting to a risk-based approach to better respond to rapid innovation and evolving public health needs. This approach will direct oversight and resources to higher-risk areas, while right-sizing requirements for those posing lower risk.

    In one initiative, Health Canada has taken steps to include targeted use of "terms and conditions" for a medical device licence. This allows specific compliance issues to be addressed while not disrupting other aspects of the operation that comply with the regulations.

    Going forward, key initiatives will help reduce pre-market requirements for natural health products and simplify approvals for non-prescription drugs. Licensing burden will be reduced on facilities working with specific lower-risk toxins and inspections where compliance is strong and risks are low will be scaled back. These initiatives will ensure that resources are used where they have the greatest impact.

  4. Streamlining regulations, simplifying rules and enhancing flexibility

    Stakeholders have expressed concerns about overlapping, unclear and complex regulatory requirements. This includes burdensome licensing and reporting processes. By streamlining these requirements, Health Canada and the Public Health Agency of Canada aim to provide a clearer and more predictable regulatory environment that supports innovation and reduces barriers for businesses.

    Initiatives under this theme include modernizing food compositional standards, updating cannabis regulations on licensing, security, packaging and reporting, and reducing administrative burden for travellers and operators by simplifying communicable disease reporting requirements.

    Other initiatives under this theme include removing certain pre-market requirements for pest control products, consolidating regulations on controlled substances, repealing and replacing outdated rules in the Quarantine Regulations and simplifying the Food and Drug Regulations.

  5. Enabling new products and technologies

    Rapid scientific and technological advances in health care, biotechnology, food production and by industry are driving the rapid creation of innovative products. Health Canada and the Public Health Agency of Canada are committed to ensuring regulations keep pace with these changes and reflect current business realities.

    To support innovation, the department and the agency are increasing regulatory flexibility and removing product- or sector-specific barriers. For example, one initiative aims to publish guidance for manufacturers of machine learning-enabled medical devices to promote rapid innovation while ensuring safety and effectiveness.

    The department and the agency are also continuing to modernize frameworks, such as those governing clinical trials, to reduce barriers and facilitate faster access to new products and technologies in Canada.

Health Canada and the Public Health Agency of Canada are presenting a total of 42 initiatives: 12 initiatives completed or near completion, and 30 that should be completed over the next 2 years or beyond.

The aim of these efforts is to create a regulatory environment that balances robust protection of public health and safety with economic competitiveness and innovation. As this is an ongoing process, the department and the agency will continue to take steps to make our regulatory processes more efficient in the coming years. Health Canada and the Public Health Agency of Canada remain committed to ongoing engagement, consultation and modernization to better serve people in Canada.

Context

Regulations are vital for safeguarding the health, safety and security of people and communities in Canada. Regulations influence many aspects of daily life. They help ensure the safety and quality of food, medications, consumer goods and products that may affect health and the environment, such as pesticides and hazardous materials.

The Government of Canada gives considerable attention to the design and implementation of regulations. However, outdated or unnecessary regulatory requirements may cause burden for regulated parties. This is often referred to as “red tape” and may include:

On July 9, 2025, the Government of Canada launched a Red Tape Review across the federal regulatory system. The review is intended to eliminate outdated or unnecessary rules and streamline the delivery of regulatory decisions.

This report is the result of the review by Health Canada and the Public Health Agency of Canada, which are responsible for protecting public health, safety, security and, in certain cases, the environment.

The department and the agency develop and administer regulations to address risks such as those associated with diseases and unsafe foods, as well as health, industrial and consumer products. Both organizations regulate several sectors that have important impacts on the Canadian economy. For example, the life sciences and biomanufacturing sector, which is one of the most regulated sectors by Health Canada and the Public Health Agency of Canada, contributes around $17.6 billion to Canada’s GDP.

The Canadian Food Inspection Agency (CFIA) also plays an important role in safeguarding food for the health and safety of people in Canada. CFIA has conducted a separate review to reduce regulatory red tape.

Read CFIA's report on reducing regulatory red tape.

Health Canada and the Public Health Agency of Canada's regulatory role

Health Canada and the Public Health Agency of Canada help protect public health and safety, and help people in Canada maintain and improve their health, by:

The core objective of Health Canada and the Public Health Agency of Canada's regulatory role is to ensure that health products, food and other consumer goods meet safety, efficacy and quality standards. The department and the agency use a risk-based approach to prioritize resources and actions based on the level of risk posed to public health, safety, and security.

As part of their regulatory role, specifically Health Canada and the Public Health Agency of Canada:

Effective regulations can help to build a healthy and prosperous society by enabling access to safe products and fostering a clean environment. As regulators, Health Canada and the Public Health Agency of Canada aim to design and implement strategic and agile regulations to protect the health, safety and security of people in Canada without creating unnecessary regulatory burden. These regulatory systems are designed to offer a level playing field for businesses by creating fair competition and increasing public trust in the products available on the market. They also aim to reduce costs to society related to adverse health effects.

The World Health Organization (WHO) has officially designated Health Canada as a WHO Listed Authority. This status is granted to national authorities that meet the highest international regulatory standards for medical products. Health Canada is engaged in significant regulatory cooperation with top regulators around the globe .

Modernizing regulatory approaches

As technology evolves, people are looking to find information quickly to help them make decisions about their health and the products they use. Health and other products available in Canada are becoming more personalized. There is also an increased demand for new products to enter the market rapidly. For example, new and emerging technologies and innovations have led to advancements in gene and cell therapies and increased use of artificial intelligence. At the same time, complex global supply chains and climate change are changing the landscape for regulators.

Health Canada and the Public Health Agency of Canada must keep pace with these changes. This means becoming more agile and efficient regulators through risk-based approaches and continuing to leverage new tools and our international relationships with trusted foreign regulators. This also means supporting new, innovative science and technologies that could improve people’s lives while maintaining appropriate safety and security considerations.

In recent years, the department and the agency have taken major steps to meet the realities of a changing landscape, including modernizing regulations. This has involved undertaking targeted reviews of regulations and regulatory practices in specific sectors, to identify ways to promote economic growth and innovation.

Learn more about the Government of Canada’s targeted regulatory reviews.

As part of this exercise to modernize regulatory approaches, Health Canada and the Public Health Agency of Canada:

These regulatory roadmaps demonstrate the department and the agency's commitment to:

Advancing red tape reduction

While many regulations have been modernized, more work is needed to further streamline rules and administrative processes to make it easier to do business in Canada. This work will also improve regulatory services and provide a more predictable regulatory environment for regulated parties, without compromising the health and safety of people in Canada.

As part of the Government of Canada's 2025 commitment to reduce red tape, Health Canada and the Public Health Agency of Canada have taken stock of the work that has been made to date and identified new initiatives that can be undertaken.

Within this report, actions under Progress achieved highlight key initiatives that have been completed or are near completion. Actions under Ongoing and future initiatives are longer-term, may require additional consultations and will be completed over the next 2 years or beyond. Some action items will require final approval from the Minister, Cabinet or Parliament before they can move forward.

All initiatives have been organized into 5 themes.

Theme 1: International alignment and reduction of trade barriers

Products that Health Canada and the Public Health Agency of Canada regulate are sold in an increasingly global marketplace. Different regulatory requirements between jurisdictions can create burden and trade barriers. They can also slow economic growth and innovation by limiting products and services from accessing the Canadian marketplace. Stakeholders have frequently expressed the need for the department and the agency to continue efforts to harmonize and further align requirements with trusted foreign regulators.

There is also an increasing need to align approaches for product authorizations and surveillance, as well as compliance and enforcement. This means relying on approvals made by trusted foreign regulators so that Health Canada may fast-track product reviews and coordinate inspections. The efforts to increase international alignment come at a critical time, as eliminating barriers to trade will reduce business costs, increase productivity and contribute to Canada's economic growth.

Theme 2: Improving client experience and service delivery

Health Canada and the Public Health Agency of Canada recognize that improving client experience and streamlining service delivery is essential. Doing so would reduce red tape barriers that can delay access to critical products. The department and the agency are taking concrete steps to make services more accessible and efficient. For example, the department and the agency are investing in digital platforms that streamline application submissions and improve transparency throughout the regulatory process. A shift toward modern, user-friendly services can reduce paperwork and speed up decision-making.

Through previous consultations, stakeholders have highlighted the importance of clear guidance and efficient communication to navigate complex regulatory requirements. Improving client experience ensures that individuals and businesses can better understand expectations and comply with regulations. These efforts also promote fairness and consistency in our service delivery, contribute to faster access to innovative products and support public health outcomes.

Theme 3: Risk-based regulating

While safeguarding public health, Health Canada and the Public Health Agency of Canada's risk-based approach to regulatory design, pre- and post-market surveillance, and compliance and enforcement plays a central role in reducing red tape. This approach involves regulating products based on their risks and uncertainties and applying appropriate oversight.

A risk-based approach ensures that:

This approach also helps direct resources to where they have the most impact. For example, in terms of compliance and enforcement, industry stakeholders may benefit from fewer inspections or simplified reporting where risks are minimal.

Slow regulatory responsiveness to quickly evolving market conditions has sometimes led to a one-size-fits-all approach, for both low-risk products and higher-risk products. This has underscored the need for a more agile, targeted and risk-based approach to regulating, so the department and the agency can respond faster to innovation as well as urgent and shifting public health priorities.

Risk-based regulation also fosters greater consistency when it comes to approving products, conducting surveillance, and taking compliance and enforcement actions. Greater consistency leads to more predictable and transparent processes. Health Canada and the Public Health Agency of Canada are continuing to refine this approach. The goal is to balance the protection of health and safety yet make the regulatory system more agile and effective.

Theme 4: Streamlining regulations, simplifying rules and enhancing flexibility

Health Canada and the Public Health Agency of Canada are revising complex regulatory frameworks and requirements that place unintended burden on industry. Industry stakeholders have indicated that they face undue burden due to overlapping or unclear regulatory requirements, complex regulatory approvals, and onerous reporting and information demands.

Streamlining regulatory frameworks and requirements would enhance service delivery for stakeholders and reduce barriers to conducting business in Canada.

Theme 5: Enabling new products and technologies

The Government of Canada has taken significant steps to support the Canadian economy by:

However, Canadian businesses may face regulatory barriers to bringing new products or services to market efficiently when regulations are outdated or lag behind innovation. The department and the agency are taking considerable steps to address these barriers, while also continuing to protect the health, safety, and well-being of people in Canada.

It's important that acts and regulations keep pace with changing technologies and reflect current business realities, challenges and opportunities. The scientific and technological advances in the health care, biotechnology, food production, industrial and commercial sectors are leading to the development of a range of innovative chemicals, food, biotechnology and health products. The COVID-19 pandemic illustrated the importance of reducing barriers to innovation and market access while also overseeing the safety, efficacy and quality of health products.

Health Canada and the Public Health Agency of Canada will continue to take steps to ensure regulatory frameworks address these barriers and support more resilient supply chains. This includes identifying areas where improvements to regulatory practices can support a more efficient movement of goods and services.

Theme 1: International alignment and reduction of trade barriers

Progress achieved

Amending the Food and Drug Regulations and the Medical Devices Regulations (designated regulatory authorities and medical device recalls)
  • Context: The Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) govern the sale of therapeutic products, such as drugs and medical devices in Canada. Some parts of these regulations were either not aligned with those of key foreign regulators or had unintended negative impacts on international trade. For example, the FDR had an outdated reference to regulatory authorities in countries that have a mutual recognition agreement (MRA) with Canada. This prevented importers from using inspection results from certain trusted foreign regulators to demonstrate that their facilities meet safety and quality standards as part of Health Canada's drug establishment licence (DEL) process. Also, unlike the requirements in other jurisdictions, the MDR required industry to report low-risk medical device recalls to Health Canada. This requirement added to their burden and reputational concerns.
  • Action: Health Canada amended the FDR to replace outdated references to international regulatory partners involved in MRAs with Canada. This has made it easier for companies to understand Canada's partnerships with other jurisdictions on drug and medical device oversight, as well as the information that Health Canada requires as part of the DEL process. The amendments also reduced requirements for testing certain novel and complex products after they are made, like radiopharmaceuticals and biologics. This allows companies to be exempted from aspects of this testing for specific products when Health Canada has a high degree of confidence in their safety.

    The department also clarified the information that companies need to provide as part of the drug establishment licensing process and removed the reporting requirement for low-risk medical device recalls in the MDR. This amendment reduced the burden on industry and aligned Canada with other countries.

  • Expected outcomes: The amendments to the FDR encourage the increased availability of advanced medical treatments for people in Canada. They are expected to help businesses by improving access to information as a result of Canada's international partnerships. Businesses will also benefit from information-sharing with trusted regulators. About 60 novel and complex products are expected to be eligible for an exemption to aspects of testing requirements. This is expected to save industry an estimated $5 million per year (in 2022 dollars). The MDR changes will also result in industry no longer needing to report low-risk recalls for medical devices. This is expected to save industry about $375,000 (in 2022 dollars) every year.

Ongoing and future initiatives

Expanding international joint reviews for pest control products
  • Context: Health Canada currently participates in joint reviews with the United States Environmental Protection Agency (U.S. EPA). However, the work is limited to harmonizing acceptable limits for pest control product residues in food to encourage trade.
  • Action: The department plans to build on work being undertaken with our international regulatory partners, which includes the United States, European Union, United Kingdom, Australia and New Zealand. Health Canada is considering expanding the scope of the current joint review process to include broader health and environmental risk aspects. This expansion is already being piloted with the United States for a new agricultural chemical and with Australia and Spain for a biological pest control product. In parallel, the department will be looking at science policy differences that contribute to discrepancies in regulatory outcomes. If regulatory outcomes are aligned, the department will look at the best way to use foreign regulatory decisions to expand scope and fast-track post-market reviews.
  • Expected outcomes: While joint reviews of pesticides may be more challenging to coordinate and manage, they also offer many intangible benefits. Joint reviews can result in pest control products being registered in participating countries at the same time. Expanding the joint review process and reviewing differences in science policy would result in efficient international regulatory cooperation, with regulatory outcomes that are more aligned. Joint reviews would also improve predictability and eliminate duplicative regulatory evaluations.
  • Timeline: Long-term: To be completed in 2-plus years. Health Canada will engage with foreign partners and industry on possible joint reviews in 2025-2026. Work would begin on any joint reviews agreed to by foreign partners and submitted by industry in 2026-2027. This work would continue in 2027-2028 as needed.
Exercising enforcement discretion on Hazardous Products Regulations (misaligned implementation timelines between Canada and the U.S.)
  • Context: Under the Canada-United States Regulatory Cooperation Council, Health Canada works with the United States Occupational Safety and Health Administration to align the requirements for workplace hazardous products. The goal is to align with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Both countries proposed amendments to their regulations in a coordinated way to align with a newer version of the GHS, but the U.S. regulations were approved significantly later than Canada's. The delay has impacted the transition periods between the U.S.'s Final Rule amending the Hazard Communication Standard and Canada's Hazardous Products Regulations (HPR). Amendments to the HPR have a transition period ending in December 2025. The United States transition period ends in January 2026 for substances and in July 2027 for mixtures. This delay is an irritant for Canadian industry.
  • Action: Health Canada would exercise enforcement discretion by deferring proactive inspections until the end of the applicable U.S. transition period for Canadian companies that import workplace hazardous products from the United States. The department would focus on promoting compliance instead.
  • Expected outcomes: Exercising enforcement discretion would allow Health Canada to focus on compliance promotion of the HPR, which would help suppliers navigate the requirements in both countries. Having 1 product label and 1 safety data sheet for hazardous products in both countries would reduce burden on companies that import hazardous products from the United States. This would not have a major impact on the health and safety of workers as Health Canada can compel compliance with the HPR at any time.
  • Timeline: Short-term: To be completed in 2025-2026.
Increasing access to drugs through international collaboration, alignment and reliance
  • Context: Gaps in the availability of health products in Canada are partly due to industry decisions related to Canada's small share of the global market. Despite having globally recognized alignment and competitive review timelines at Health Canada, stakeholders have recently raised concerns about the time it takes to get products to market. Collaboration with other jurisdictions can help decrease the time to approval and increase the number of new products available. There is a growing international interest in collaborative reviews, work-sharing and relying on approvals by comparable regulators.
  • Action: The legislative amendments made in 2024 are an example of how this is being achieved. The Minister of Health can now make an Order deeming that certain legislative and regulatory requirements related to specific, identified classes of products are met based on authorizations by a comparable foreign regulatory authority (“reliance”). Health Canada wants to build upon this work by advancing an Order in 2026 to increase the use of reliance, as well as data and information and work-sharing with regulatory partners. This will facilitate access to needed drugs in Canada. Enhanced international regulatory alignment reduces burden for industry and can support increased health product submissions to Canada. Health Canada has been focused on supporting international alignment through multilateral fora, such as the International Council of Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and through recent regulatory modernization activities. As an additional example of these efforts, Health Canada could solicit data from companies during drug reviews rather than relying on a single submission of all data at the beginning of the review process. This would allow the department to request clarifications and additional data from industry without stopping the review. This approach aligns with international regulators and it is anticipated that it will support faster access to drugs in Canada. It will also reduce the number of negative decisions by the regulator without compromising safety.
  • Expected outcomes: Greater international collaboration, work-sharing and reliance with regulatory partners would reduce burden for industry. Health Canada also expects that more submissions would be evaluated without compromising safety. Increased use of work-sharing and reliance could also help accelerate the department's approval of certain health products. An example of this is evidenced through reviews conducted with like-minded regulatory authorities under the Access Consortium, which reduced median rollout times by roughly 36%. As well, international collaboration activities reduced the time period for processing oncology drug applications to Canada by about 5 months. Better alignment, increased reliance, and more consistency among comparable foreign regulatory authorities would lead to greater efficiency, certainty and new marketing opportunities for industry, supporting increased and more timely access to drugs in Canada.
  • Timeline: Medium-term: To be completed in the next 2 years. The target date for a Ministerial Reliance Order that will enable greater use of reliance and work-sharing is summer 2026.
Expanding mutual recognition agreements
  • Context: Canada participates in several mutual recognition agreements (MRAs). These agreements make it possible for Canada and other countries to formally agree to recognize each other's good manufacturing practices (GMP) compliance programs for drugs and medicinal products. The MRA approach is an effective way for Canada to enhance international regulatory cooperation and maintain high standards of product safety and quality, while reducing burden on industry and government. In the absence of MRAs, facilities around the world may need to be inspected by Health Canada as well as by international regulators, which creates duplication for inspectors and places burden on facilities.
  • Action: Canada's existing MRAs save Health Canada from conducting inspections for over 2,500 foreign manufacturing facilities every year. Health Canada proposes to expand the use of MRAs and other reliance tools, such as the Single Inspection Program, to minimize duplication of inspections.
  • Expected outcomes: Expanding MRAs into other jurisdictions opens up more opportunities to develop closer and stronger relationships among regulatory authorities. It would also help to harmonize good manufacturing practices without diminishing Canada's high health and safety standards. There would be less burden on regulated parties and a more efficient use of Health Canada's resources.
  • Timeline: Long-term: To be completed in 2-plus years. The department will engage with trusted foreign regulators with whom Canada has important levels of trade and work towards establishing formal agreements.

Theme 2: Improving client experience and service delivery

Progress achieved

Issuing an Exemption Order respecting the labelling requirement for certain natural health products
  • Context: Health Canada introduced new labelling requirements for natural health products (NHPs) to improve consumer safety. The department wanted to ensure labels are clear and readable, and the information is consistent. Stakeholders had concerns about the new requirements. They said guidance around compliance was not clear, label formatting was too prescriptive and it was hard to fit the required information on small packaging. These challenges increased administrative burden and costs, especially for small businesses. This may have prevented some products from being marketed.
  • Action: A temporary compliance exemption for the new labelling requirements allows businesses to follow the existing labelling requirements for NHPs licensed between June 21, 2025, and June 21, 2028. Further conversations can also take place to address outstanding challenges to updating product labels, which may include additional regulatory amendments. While the exemption is in place, Health Canada will work with industry to address stakeholder concerns. The department will then update guidance and introduce flexible labelling requirements through targeted regulatory amendments as part of the initiative Reducing Red Tape for Natural Health Products and Non-prescription Drugs.
  • Expected outcomes: This exemption should benefit businesses and consumers. Businesses will be able to defer costs for label updates. They will also have more time to understand the new regulations, consult with Health Canada and make changes to product labels, as needed. They may also be able to bring new products to test the market. Consumers would continue to have access to a wide variety of NHPs, as the exemption would prevent potential product shortages due to non-compliance.
Modernizing non-compliance notices under the Human Pathogens and Toxins Act
  • Context: The only way to deal with minor non-compliance issues under the Human Pathogens and Toxins Act was through a formal notice of non-compliance. This process was burdensome, requiring quick responses even for minor or administrative matters. It also affected a company's risk rating, which led to more frequent inspections.
  • Action: In October 2024, the Corrective Action Report (CAR) was created to reduce administrative burden. The CAR is an informal request sent to a regulated facility to identify areas of improvement. It is sent in advance of a formal notice of non-compliance. Unlike the notice of non-compliance, the CAR does not require the same paperwork, deadlines or regulatory burden. It lets facilities correct minor administrative issues without affecting their risk rating. The Public Health Agency of Canada is able to handle minor administrative compliance issues more fairly and with more flexibility, rather than using a strict or penalty-focused approach.
  • Expected outcomes: The CAR replaces the notice of non-compliance for less serious compliance issues. As a first step, it makes the compliance process easier and more collaborative, while still protecting public health. It provides regulated facilities more time to respond and does not affect their risk rating or lead to more inspections. This saves time and money, and is more collaborative.

Ongoing and future initiatives

Modernizing labels for pest control products
  • Context: There is a lack of consistency in how pesticide labels are organized or worded. Also, the Pest Control Products Regulations require all pesticide product labels to be paper-based. Electronic labels or internationally standardized formats, such as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) label, are not allowed. As a result, labels are inconsistent, difficult to read, out of date or do not align with global best practices. Users find it hard to locate and understand the most up-to-date critical safety information and how to use the product. This can impact health and environmental outcomes.
  • Action: Health Canada is working on a tool to help applicants create a pesticide label. This will ensure that pest control product labels are more consistent and readable. The tool is a self-serve, web-based form that guides applicants through the process of making a label and automatically applies label standards. Health Canada is also proposing amendments to the regulations that would support structured labels, allow electronic labels to be used and recognize GHS standards for chemical classification and labelling. The final regulations are expected to be published in the Canada Gazette, Part II in fall 2027.
  • Expected outcomes: The proposed changes should make labels more readable and help users find and understand the recent and critical safety information. The use of electronic labels would also reduce costs for regulated parties. This initiative supports regulatory cooperation in Canada and internationally, ensuring consistency while enhancing safety and usability. Permitting the voluntary use of GHS labels would allow registrants to align with international standards. This could open up access to other markets and lead to regulatory efficiency. Health Canada is expected to save $205,000 the first year after the structured labelling tool goes into production and approximately $1.7 million over 3 years after its implementation. Similar savings are also expected for industry since the labelling tool will assist with label version control and streamlined label creation and annotations.
  • Timeline: Medium-term: To be completed in the next 2 years. The structured label tool will be available for voluntary-use in September 2025 for commercial and domestic agriculture products, structural products and seed treatment products. The publication of a consultation document is anticipated for spring 2026. Health Canada is aiming to publish a regulatory proposal in the Canada Gazette, Part I in winter-spring 2027 followed by the final regulatory amendments in the Canada Gazette, Part II in fall 2027.
Launching a secure web portal for pest control products
  • Context: Under the current pesticide regulatory system, applications are submitted and processed manually. Companies must contact Health Canada to get information on their applications. This is not efficient and causes more red tape for both industry and government.
  • Action: Health Canada proposes to implement a secure, cloud-based "single window" platform for managing regulatory documents. Registrants would be able to upload and track their submissions in real time.
  • Expected outcomes: The cloud-based platform would reduce the need for email communications, and streamline the submission and tracking of applications. Companies would receive status updates and notifications on their files in real time, which supports faster and more transparent processing of an application. Health Canada is expected to save $150,000 per year through this initiative since it will result in better quality applications and less clarification requests for the department. Similar savings are expected for industry since they will have direct access to the submission status of pest control products.
  • Timeline: Short-term: To be completed in 2025-2026, with a target completion date in March 2026.
Reducing administrative burden in the cannabis program
  • Context: Health Canada has published numerous forms and guidance documents for parties regulated under the Cannabis Act. These documents set out requirements relating to applications and other regulatory processes, such as information that must be submitted as part of an application for different types of licences. These requirements can impose additional administrative burden on regulated parties.
  • Action: Health Canada has begun reviewing different forms and guidance documents to assess and streamline the administrative requirements imposed on regulated parties. The department intends to simplify these documents to reduce administrative burden and clarify how to comply with the regulations.
  • Expected outcomes: This review would reduce the administrative requirements imposed on federal licence holders and other regulated parties. It would lead to reduced costs and time spent complying with the requirements.
  • Timeline: Short-term: To be completed in 2025-2026. Health Canada is aiming to finish reviewing the guidance documents in 2025-2026 and to publish the revised versions starting in 2026-2027.
Launching a secure industry portal for cosmetics notifications
  • Context: Manufacturers and importers of cosmetics are required to notify Health Canada within 10 days after they first sell a cosmetic product. However, the department's information technology (IT) platform, which serves as the repository for cosmetics notifications, is causing undue administrative burden for industry. Health Canada is also receiving more low-quality, inaccurate submissions of notifications, which must be corrected manually. Internal partners and external stakeholders, including industry, have been consulted. They have expressed strong support for a modernized cosmetics notification system, which would help align Canada with international counterparts.
  • Action: As part of a larger initiative to replace an aging IT system, Health Canada is proposing a new secure online industry portal for cosmetic notifications. The portal would have automated and interactive features. Regulated parties would be able to manage their own submissions with minimal intervention from Health Canada. Users would be prompted to resolve errors in real time. The portal would increase transparency and save both time and money.
  • Expected outcomes: Regulated parties would be able to meet cosmetic notification requirements more easily and manage their own submissions. The portal would also significantly improve service delivery, reduce the time program officers spend on duplicate or incorrect submissions and streamline the cosmetic notification process.
  • Timeline: Long-term: To be completed in 2-plus years. Health Canada will develop a proposal for a new enterprise-wide solution once a governance process for IT projects is in place.
Updating guidance on elements for the risk management plan required under the Human Pathogens and Toxins Regulations
  • Context: The Human Pathogens and Toxins Act requires that anyone working with human pathogens or toxins must have a licence when storing, using or disposing of these agents. Licence applicants who intend to carry out scientific research are required to develop a risk management plan before they can obtain a licence. However, the regulations do not clearly explain what the plan should include. This has caused confusion and delays in processing licences. In a 2024 survey, companies said they support efforts to make the expectations for these plans clearer.
  • Action: The Public Health Agency of Canada plans to update guidance on how licence applicants can meet the requirements for the risk management plan.
  • Expected outcomes: The updated guidance should reduce the number of incomplete submissions and speed up licence approvals by making the review process more straightforward. Industry would be able to understand expectations before they apply. It also supports fairness and transparency in how the regulations are enforced.
  • Timeline: Long-term: To be completed in 2-plus years (to develop standard guidance and undertake the consultation process). The agency has consulted with stakeholders on the concept, and regulated parties are supportive of the proposed changes. The standard guidance development process, including additional consultations, will occur prior to its finalization, allowing stakeholders to follow its progress in real-time.
Developing recommended training pathways for biological safety officers
  • Context: The Human Pathogens and Toxins Regulations establishes the qualifications and functions of a Biological Safety Officer (BSO) which includes knowledge of applicable biosafety and biosecurity policies, standards and practices. The Public Health Agency of Canada's Training Portal has many free courses on biosafety and biosecurity, but there is no clear guidance or a suggested plan for BSOs to follow. This causes inconsistent training, duplicated efforts and confusion about which courses are required.
  • Action: The Public Health Agency of Canada proposes to simplify internal processes to make it easier for licence holders to onboard new BSOs with clear recommended training. Role-specific training paths would be developed in the training portal. Course sequences for BSOs would be recommended based on regulatory requirements and best practices.
  • Expected outcomes: The new training paths for BSOs would make it easier for them to know what training is recommended. Standardized training recommendations would ensure that BSOs take only necessary courses. BSOs would be able to navigate the training portal more easily and finish appropriate training faster. Inspectors would be able to check training compliance more quickly and consistently.
  • Timeline: Medium-term: To be completed in 2 years. The agency expects to consult with stakeholders within the next 18 months on progress being made on this initiative.
Streamlining inspection approaches
  • Context: Certain regulated parties are subject to multiple inspections for products that fall under separate regulatory frameworks. In addition, Health Canada conducts inspections for both routine purposes and targeted projects. Together, this often results in multiple different inspections of a single regulated party in a given calendar year.
  • Action: Health Canada proposes to streamline its approach by targeting a broader range of activities with fewer inspections, as well as designating inspectors to conduct inspections across multiple product lines.
  • Expected outcomes: This approach would consolidate inspections for regulated parties and ensure that their time and resources are used more efficiently. This would be less disruptive to their daily operations and the time and effort needed to respond to inspectors would be reduced.
  • Timeline: Long-term: To be completed in 2-plus years. Pilot inspections are planned for spring 2026.
Co-locating certain compliance and enforcement functions with inspections
  • Context: Certain compliance and enforcement functions at Health Canada are shared across multiple branches. This can result in regulated parties having to access the department in different ways, with different service standards and timelines to meet requirements.
  • Action: Where possible, Health Canada proposes to realign certain internal compliance and enforcement roles and responsibilities to create "single windows" for regulated parties. The department also proposes to use digital tools to respond to client inquiries on demand.
  • Expected outcomes: Re-aligning internal compliance and enforcement functions would centralize compliance and enforcement inquiries into single windows and speed up response times. Best practices with common functions would be more easily shared across programs. This would result in enhanced consistency across programs.
  • Timeline: Long-term: To be completed in 2-plus years.

Theme 3: Risk-based regulating

Progress achieved

Amending the Medical Devices Regulations (MDEL terms and conditions)
  • Context: Canada's regulatory framework for monitoring the safety of medical devices after they enter the market is important for protecting public health. Medical device establishment licences (MDELs), which make it possible to conduct licensable activities, are part of this framework. An MDEL holder may sometimes conduct activities that do not fully comply with the act or the regulations. When Health Canada becomes aware of health risks associated with these activities, regulatory action needs to be taken. However, Health Canada's enforcement tools do not allow the department to respond to non-compliance by MDEL holders in a targeted and agile manner.
  • Action: To increase the department's ability to monitor or restrict specific non-compliant activities, Health Canada introduced terms and conditions in the Medical Devices Regulations (MDR) in 2024. Terms and conditions allow Health Canada to impose specific restrictions or corrective actions rather than suspending a company's operations. Thus, Health Canada can address health risks without impacting the availability of critical medical devices in Canada. This would also allow people in Canada to have continued access to safe and effective medical devices. The overall result is a more strategic and targeted response for mitigating risks to health and safety when companies are non-compliant.
  • Expected outcomes: Terms and conditions will be used to increase the department's ability to manage non-compliances related to MDELs without impeding access to medical devices in Canada. Licence holders will have more flexibility to continue operating while non-compliances are addressed.
Discontinuing reviews of food processing aids and incidental additives
  • Context: Under the Food and Drug Regulations, there is no requirement for the authorization of processing aids and incidental additives, which are substances used in food processing. Health Canada considers these substances to be low-risk. The food industry is responsible for ensuring that non-food chemicals used in their facilities are safe and suitable for their intended use. These substances are subject to post-market surveillance and could be further assessed for safety, as necessary. In the past, the department has, upon request, voluntarily assessed the safety of these substances and provided letters of no objection where appropriate. These letters confirm that Health Canada has no safety concerns with the substance.
  • Action: Since these substances are considered low-risk, Health Canada decided to stop the voluntary review of these substances. As a result, the department stopped receiving submissions as of December 31, 2024. This reduced administrative burden and allowed the department to place available resources and efforts on high-risk, high-priority areas and activities.
  • Expected outcomes: In a typical year, Health Canada received over 250 incidental additive and 30 processing aid submissions seeking to obtain a Letter of No Objection. By removing this activity, the review of these submissions is no longer required, resulting in reduced burden for the department and industry. Based on previous estimates to submit a request seeking a Letter of No Objection, the savings to industry could potentially be as much as $3.5 million per year.
Adopting virtual inspections by the Centre for Biosecurity
  • Context: During the COVID-19 pandemic, the Public Health Agency of Canada's Centre for Biosecurity developed virtual inspections as a new method for biosafety inspections of facilities subject to the Human Pathogens and Toxins Act.
  • Action: The Centre for Biosecurity piloted virtual inspections for regulated facilities that work with lower-risk human pathogens or toxins. Because this approach saved time and money, risk-based virtual inspections were added as a new type of inspection and became a regular part of the inspection process in 2023.
  • Expected outcomes: The pilot showed that the option of virtual inspections saved around 20% in travel costs, which allowed in-person inspections to focus on higher-risk facilities. Virtual inspections also made it easier to reach remote locations. In 2023, the inspection approach was updated to include a mix of virtual (30%) and in-person (70%) inspections, with flexibility to adjust as needed. Virtual inspections reduced administrative burden and gave facilities more flexibility. They took less time, allowed facilities to operate during the inspection, involved fewer participants and removed the need to provide meeting space or a guide for inspectors.
Applying continuous oversight and proportional effort for pest control products
  • Context: Health Canada reviews registered pest control products every 15 years, as required by the Pest Control Products Act. This cycle ensures products continue to meet current scientific and regulatory standards. However, new scientific information is not automatically integrated when it becomes available. The department must then re-evaluate pest control products, which consumes resources due to in-depth re-evaluations. Health Canada has now improved the process by proactively monitoring emerging science and responding more quickly with regulatory actions when necessary. This updated process also allows the department to better consider the time period for product re-evaluations. This helps the department focus resources and evaluations on health and environmental areas with higher potential risks, using a standardized science-based framework. These changes will lead to more predictable and timely decision-making, especially during re-evaluation periods.
  • Action: The initiative applies transparent, consistent and predictable oversight throughout the entire regulatory lifecycle of a pest control product, based on its specific risks. These changes are being implemented through existing policies and updated processes.
  • Expected outcomes: Companies can now expect greater efficiency and clarity, since Health Canada's proactive monitoring of emerging science ensures regulatory actions are timely and targeted. By consistently directing resources toward pesticides with the highest potential risk, the process reduces unnecessary delays and uncertainty for lower-risk products. This data-driven, predictable framework enables companies to plan more effectively, lowers compliance costs, and accelerates market access for innovative solutions. Companies benefit from a more transparent, responsive and efficient regulatory environment that supports competitiveness and innovation.

Ongoing and future initiatives

Amending the Medical Devices Regulations (establishment licences)
  • Context: The Food and Drugs Act and the Medical Devices Regulations establish the framework to ensure the safety, quality and effectiveness of medical devices available to people in Canada. Health Canada oversees the compliance and enforcement of medical device establishment licences (MDEL), which make it possible for companies to conduct licensable activities, such as importing and selling medical devices safely and effectively. MDELs are issued to both Canadian and foreign companies based on the types of activities they conduct. Industry has said that the current regulations are burdensome and create challenges for innovation and competitiveness, which may discourage them from operating in Canada. This may negatively affect the supply of medical devices in Canada.
  • Action: In fall 2025, Health Canda plans to release draft changes to the regulations to support a more risk-based approach and clarify the MDEL requirements. One key risk-based update the department would make is to no longer limit Canadian MDEL holders to only import from foreign distributors who also have an MDEL. This would help reduce redundancy for stakeholders. The changes would also clarify that MDEL holders must have written procedures to safely manage health and safety risks associated with their MDEL activities. This would help clarify expectations for MDEL holders.
  • Expected outcomes: Allowing Canadian MDEL holders to import from foreign distributors without an MDEL would reduce unnecessary duplication and better align with international practices. Updating regulations to make them clearer would help set consistent expectations and standardize requirements. They would also improve the department's ability to better identify and monitor medical devices and MDEL companies that pose health risks. Under the proposed changes, some foreign distributors would no longer require an MDEL. Foreign distributors would save about $333,000 in fees per year or $2.3 million (present value) over 10 years. (While monetary benefits to foreign distributors are not considered because they are outside of the Canadian context, for cost-benefit analysis (CBA) purposes, they are acknowledged.)
  • Timeline: Short-term: To be completed in 2025-
Modernizing drug establishment licencing, Phase 2
  • Context: Under the Food and Drug Regulations all Canadian drug establishments must have a drug establishment licence (DEL) to conduct licensable activities in Canada. While Health Canada oversees these activities to mitigate and manage risks posed to consumers, drug products are becoming more complex and global supply chains are expanding. This makes it more challenging to monitor a company's compliance and take enforcement action. Given the pace of innovation, it is timely to conduct a comprehensive review of how the department's program for overseeing these activities. Stakeholders have also raised that some of the department's licensing requirements are burdensome and inflexible.
  • Action: To better respond to rapid innovation and evolving public health needs, Health Canada plans to modernize the oversight of the DEL process. The proposed updates would introduce a more flexible, risk-based approach to how the department manages potential health and safety risks. For example, terms and conditions are a tool used by the department to help manage potential risks by imposing specific restrictions or corrective actions. Improving the flexibility of this tool would allow companies to address specific areas of non-compliance without having to suspend their overall operations. The proposed updates would also remove the need for companies to submit health and safety related evidence every year. A risk-based cycle for assessing evidence would reduce burden for industry and the department. The department would also have new tools to address non-compliant foreign building sites listed on the DEL without affecting activities in establishments that are meeting requirements.

    Note: This initiative is the second phase of the plan to modernize the DEL program and keep up with the complexities of the drug industry.

  • Expected outcomes: The proposed updates would enhance regulatory flexibility and promote a risk-based approach to compliance and enforcement. They would reduce unnecessary administrative burden, align better with international practices and address drug industry concerns, without compromising health and safety. These changes may also improve drug availability in Canada and support the Canadian drug industry.
  • Timeline: Long-term: To be completed in 2-plus years. A pre-consultation notice of intent is anticipated for spring 2026. The draft regulations are expected to be pre-published in the Canada Gazette, Part I in fall 2026 or winter 2027. Health Canada is targeting final publication in the Canada Gazette, Part II in 2028.
Reducing red tape for natural health products and non-prescription drugs
  • Context: Health Canada regulates natural health products (NHPs) and non-prescription drugs (NPDs), which are both lower-risk therapeutic products. The Natural Health Product Regulations apply to a range of NHPs, with varying risk levels, yet all are subject to the same rules. Moreover, the requirements set out in the Food and Drug Regulations for NPDs are outdated and inflexible, with the same rules for both prescription and non-prescription drugs. The current approach to regulating NHPs and NPDs results in oversight that is disproportionate to both risk and uncertainty. It also creates unnecessary burden for industry.
  • Action: Health Canada plans to introduce a simple registration process for certain NHPs and NPDs, along with flexible risk-based monitoring for all NHPs and NPDs. The department plans to amend the regulations for NHPs by making labelling requirements more flexible and reducing authorization requirements in areas where oversight is more appropriate after the product is authorized. The department also plans to introduce modern, flexible regulations for NPDs with simplified requirements to fast-track product approvals.
  • Expected outcomes: The proposed approach would simplify both application requirements and post-authorization obligations for NHPs and NPDs. Industry would have more flexibility to meet their obligations. This approach would also encourage more products to be brought to the Canadian market and support flexible, risk-based post-authorization vigilance.
  • Timeline: Long-term: To be completed in 2-plus years. Health Canada anticipates publishing a regulatory proposal for NHPs and NPDs in the Canada Gazette, Part I for consultation within 3 years.
Amending the Human Pathogens and Toxins Regulations to provide for licensing exemptions for low quantity toxins
  • Context: Human pathogens and toxins can harm people and public safety, whether by accident in a lab, through an infected worker or intentionally through a criminal act like terrorism. The Human Pathogens and Toxins Regulations (HPTR) monitor and control public safety by requiring licences for facilities that work with these materials. However, the current regulations do not allow exemptions for sites that use small amounts of certain toxins that pose little risk to the public. This is seen as an unnecessary burden for those facilities.
  • Action: The Public Health Agency of Canada plans to update the HPTR to exempt facilities that work with small amounts of certain toxins from needing a licence. This will not apply to facilities that work with human pathogens. This is in line with the current risk-based approach of the regulations.
  • Expected outcomes: The proposed regulatory updates would make things easier and less costly for lower-risk facilities. The Public Health Agency of Canada would be able to focus its activities on higher-risk facilities.
  • Timeline: Long-term: To be completed in within 2-plus years. A pre-consultation is anticipated for spring 2026 and a regulatory proposal is anticipated to be published in the Canada Gazette, Part I in spring 2027.
Expanding planned inspection cycles for lower-risk products
  • Context: The products that Health Canada regulates have different risk profiles. As well, the regulated companies vary in size and the types of products they sell. There is an opportunity to improve the level of oversight in relation to a product's risk level.
  • Action: Health Canada plans to better align the frequency of its proactive inspections and overall oversight with a product's risk level and a company's history of compliance. This may mean scaling back inspections where compliance is high or risk is low, or introducing lighter-touch oversight. This approach would lead to fewer low-risk compliance verification activities and introduce measures that allow for lighter-touch oversight.
  • Expected outcomes: Expanding planned inspection cycles for lower-risk products would give regulated parties additional time to prepare for routine inspections. Resources would be targeted to areas of high non-compliance or high-risk.
  • Timeline: Long-term: To be completed in 2-plus years.

Theme 4: Streamlining regulations, simplifying rules and enhancing flexibility

Progress achieved

Amending certain regulations concerning food additives and compositional standards, microbiological criteria and methods of analysis for food
  • Context: The Food and Drug Regulations contained outdated food compositional standards, which set rules for the ingredients, strength, potency, purity and quality of certain foods. Health and safety rules, such as microbiological criteria and official methods of analysis, were also included in food compositional standards, which has caused confusion and duplication. The rigid frameworks within the regulations have also been a barrier to adapt to new science, innovation or emerging health risks. These challenges have led to higher costs, delayed market entry, reduced global competitiveness and limited consumer access to innovative products.
  • Action: Health Canada, working with the Canadian Food Inspection Agency (CFIA), modernized the outdated frameworks governing food compositional standards and certain food safety requirements. Health Canada also consolidated the food additive rules and removed outdated requirements. These changes would help ensure that food safety standards reflect the latest scientific advancements and industry practices.
  • Expected outcomes: The changes would reduce red tape and foster a more dynamic food sector. The continued use of incorporation by reference allows the department to update food safety requirements without having to amend the FDR each time. This requirement covers technical details like microbiological criteria, acceptable methods of analysis, and permitted food additives and their conditions of use. This approach means that food safety rules can be quickly adjusted to reflect new science or emerging risks. Businesses will benefit from streamlined administrative processes and an agile regulatory system. The changes will save time and effort and improve clarity and responsiveness. By aligning more closely with international standards, amendments will reduce trade barriers, as well as improve interprovincial trade and the importation of foods.
Revising guidance on food processing aids and incidental additives
  • Context: With Health Canada's decision to discontinue letters of no objection for incidental additives and processing aids (visit Discontinuing reviews of processing aids and incidental additives), industry stakeholders need guidance on how to properly categorize and distinguish these substances from one another. The CFIA also needs clarification to help carry out its compliance and enforcement activities.
  • Action: Health Canada published the revised Guidelines for Incidental Additive Submissions in August 2025. The guidance spells out considerations for different types of chemicals used in food processing facilities. Health Canada is also revising the Policy for Differentiating Food Additives and Processing Aids, which will be published by December 2025.
  • Expected outcomes: The revisions will make it easier for industry to determine if a substance is a food additive or a processing aid. The revisions will make the instructions on how to safely use incidental additives clearer. The changes will also help manufacturers determine which substances fall under which category and how to comply with the requirements. They will also support CFIA's compliance and enforcement activities.
Streamlining the requirements of the Cannabis Regulations
  • Context: After almost a century of prohibition, Canada became the first major developed country to legalize and regulate cannabis when the Cannabis Act and its regulations came into force in 2018. Given the wide-ranging impacts of this change from prohibition to legal, and regulated access, Parliament established a requirement for the act to be reviewed 3 years after its coming into force. In September 2022, the Minister of Health, the Minister of Mental Health and Addictions and the Associate Minister of Health appointed an independent expert panel to conduct a review. Some recommendations from this review focused on reducing regulatory burden on regulated parties while maintaining key public health and safety controls.
  • Action: In line with some of the expert panel's recommendations to streamline requirements, Health Canada amended parts of the cannabis regulatory framework in March 2025. The changes concern licensing, personnel and physical security, production, packaging and labelling, and record-keeping and reporting.
  • Expected outcomes: These changes simplify the regulatory requirements and lower compliance costs for businesses. The total benefit for companies is estimated to be $296 million (present value) over 10 years.

Ongoing and future initiatives

Amending the Pest Control Products Regulations (product exemptions and pest control devices)
  • Context: Health Canada is modernizing the Pest Control Products Act (PCPA) and Pest Control Products Regulations to reduce administrative burden and regulatory uncertainty while continuing to protect human health and the environment. This is in response to stakeholder concerns about unclear regulations, especially for new technologies.
  • Action: Health Canada proposed to amend 2 main areas, including product exemptions and pest control product devices. The product exemption amendments would authorize certain pest control products, such as low-risk food-based products and indigenous macro-organisms, under certain conditions. This would remove any pre-market registration requirements. The device amendments would clarify that all devices are regulated under the regulations. They would also allow some low-risk devices, such as sprayers and mechanical traps like fly traps and mousetraps, to be authorized without extra conditions.
  • Expected outcomes: The proposed amendments would reduce regulatory burden by eliminating unnecessary registration requirements for low-risk products and devices. This would allow businesses, especially those developing novel technologies, to enter the Canadian market more easily. Clearer definitions would also reduce confusion and delays for businesses looking to register their products.
  • Timeline: Medium-term: To be completed in 2 years. A Canada Gazette, Part I consultation on the proposed amendments is anticipated for winter 2026. Regulatory amendments are anticipated for fall 2026.
Amending the Pest Control Products Regulations (antimicrobial-treated Class I medical devices)
  • Context: The Pest Control Products Act (PCPA) and the Pest Control Products Regulations (PCPR) regulate the use of pesticides in Canada. Health Canada asked stakeholders to provide feedback on proposed amendments to the regulations that would streamline the regulatory framework. This included a proposal to exempt certain antimicrobial preservatives and the products they treat from the PCPA when used on certain products regulated under the Food and Drugs Act (FDA). The changes removed rules for Class II, III and IV medical devices that use antimicrobials for preservation. After publishing these changes and in response to stakeholder feedback, Health Canada again considered whether exempting Class I medical devices treated with an antimicrobial preservative and the preservatives used on them from the PCPA and if this would be consistent with the act's objectives.
  • Action: In June 2025, Health Canada asked for feedback on a proposed change to the PCPR. This change would remove duplication with the Medical Devices Regulations (MDR) by extending the current exemption of antimicrobial-treated Class II, III and IV medical devices to also include antimicrobial-treated Class I medical devices.
  • Expected outcomes: This change would reduce administrative burden and regulatory duplication because the health and environmental risks of antimicrobial-treated Class I medical devices would already be managed under the FDA and the MDR. These devices would no longer be subject to the PCPA. This would streamline the regulatory process without affecting health and environmental protections. It's expected there will be minimal impact on stakeholders, as the new regulations align with current practices and reduce unnecessary regulatory overlap.
  • Timeline: Short-term: To be completed in 2025-2026. Health Canada plans to publish the final changes to the regulations in the Canada Gazette, Part II in fall 2025.
Consolidating and modernizing regulations under the Controlled Drugs and Substances Act
  • Context: The Controlled Drugs and Substances Act is a legislative framework for managing substances that can affect mental processes and pose risks to public health and safety if used inappropriately or diverted to the illegal market. However, the rules for different types of substances are not consistent. This has caused unnecessary burden and challenges for companies trying to administer and comply with the legislation.
  • Action: Health Canada plans to merge several existing controlled substances regulations and class exemptions into 1 new set of regulations. These would be known as the Controlled Substances Regulations. The proposed regulations would apply to all types of controlled substances. They would clearly outline the scope for certain authorized individuals or organizations handling these substances, such as pharmacists, practitioners, hospitals and individuals. The department would also standardize the record-keeping, security and reporting requirements for controlled substances.
  • Expected outcomes: The new consolidated regulations would streamline record-keeping and reporting requirements. They would also remove certain regulatory barriers, which would make it easier for companies to comply with regulatory requirements. This would save costs and time. Pharmacists would not have to apply for a dealer's licence to process prescriptions on behalf of another pharmacy, which would help them operate more efficiently. The net benefits of the proposal to industry are estimated to be $1.08 million (present value) over 10 years.
  • Timeline: Short-term: To be completed in 2025-2026. The final regulations are expected to be published in the Canada Gazette, Part II in fall 2025.
Streamlining the Cannabis Tracking System Order
  • Context: Health Canada monitors the movement of cannabis across the supply chain, in conformance to the Cannabis Tracking System Order(CTSO)made under the Cannabis Act. This helps prevent cannabis from being diverted into the illegal market or illegal cannabis from entering the legal system. As set out in the CTSO, Health Canada requires certain federally licensed businesses and provincial and territorial groups that distribute cannabis wholesale and sell it at the retail level are required to submit monthly reports.
  • Action: Health Canada is asking businesses to provide feedback on potential amendments to the CTSO. The goal is to simplify reporting requirements, reduce regulatory burden and create operational efficiencies, while still meeting the objectives of the tracking system.
  • Expected outcomes: The changes should reduce administrative burden for businesses by making it easier to meet reporting obligations.
  • Timeline: Medium-term: To be completed in 2 years. A notice of intent was published on August 30, 2025, to collect feedback on potential changes. A Canada Gazette, Part I consultation on proposed amendments is expected in 2026.
Limiting pest control product renewals
  • Context: When a product is registered under the Pest Control Products Act (PCPA), Health Canada specifies the period for which the registration is valid. Companies can apply to renew product registrations for up to 5 years. This process requires companies to submit paperwork and pay a fee. A company can choose to pay to rely on the data submitted by another company when registering an equivalent product. In these cases, renewals are necessary to ensure there is an agreement in place for companies relying on data. However, renewals do not involve rigorous health or safety assessments, which are conducted through other methods. This creates administrative burden for some companies and for the government since the fee paid by companies does not cover the full cost of processing these renewals.
  • Action: Health Canada plans to amend the regulations under the act so that only companies relying on another company's data would be required to renew their product registrations. This would remove the need for most routine renewals.
  • Expected outcomes: This change should reduce administrative burden. The department estimates at least 500 renewals each year over the next 5 years would not be needed. This would save companies about $40,000 per year in product registration renewal fees. Not having to submit renewal applications and pay application fees would also save time and cost for most companies.
  • Timeline: Medium-term: To be completed in 2 years. A pre-consultation is anticipated to take place in spring 2026, followed by a Canada Gazette, Part I consultation expected in winter 2027.
Repealing of Matches Regulations
  • Context: The Matches Regulations establish requirements for the quality of the match head and the match splint. The requirements are meant to reduce the number of incidents involving fragmenting or detached match heads. The regulations also prohibit matches that contain any white phosphorus, which is highly toxic. However, several deficiencies and industry irritants have been identified with the regulations, such as outdated testing and labelling requirements.
  • Action: Health Canada plans to repeal the current regulations. While white phosphorus is no longer used to manufacture matches, protections from this substance could be upheld under the Canada Consumer Product Safety Act.
  • Expected outcomes: Repealing the regulations would remove compliance burden for industry without compromising the safety of people in Canada. There are currently minimal compliance concerns and the regulations emphasize quality rather than safety requirements.
  • Timeline: Medium-term: To be completed in 2 years. The department will explore how these amendments can be made as part of an omnibus approach to streamline the timelines.
Amending Section 37 of the Food and Drugs Act (exports)
  • Context: Food products that are manufactured in Canada but sold outside of the country must comply with certain provisions of the Food and Drugs Act (FDA) and the Food and Drug Regulations. This presents a challenge for manufacturers, who may incur significant costs to meet standards for the Canadian market that are not required for foods that are only for export. It can also put them at a competitive disadvantage in international markets. In addition, food export requirements in the FDA do not align with the Safe Food for Canadians Act and the Safe Foods for Canadians Regulations. This has created unnecessary barriers for certain Canadian manufacturers who wish to produce packaged foods destined solely for sale in foreign markets.
  • Action: Health Canada is considering amending the FDA to address requirements for food products intended for export.
  • Expected outcomes: Amendments to the FDA for food could remove unnecessary barriers to manufacturers looking to enter the export market. This would help them compete in both domestic and international markets. The amendments would also provide a more consistent, clear and predictable regulatory environment so that manufacturers will understand the requirements they need to follow to export food products. The changes would also remove misalignment with the Safe Food for Canadians Act and the Safe Foods for Canadians Regulations for food export requirements.
  • Timeline: Medium-term: To be completed in 2026-2027. The department will explore the earliest opportunity to include these amendments as part of a Budget bill or other appropriate legislative mechanism.
Simplifying the Food and Drug Regulations
  • Context: The Food and Drug Regulations have been amended several times over the years. Amendments have been made to keep up with advances in science, as well as Health Canada's evolving role related to the safety, efficacy and quality of health products and food. This has resulted in a complex set of regulations with some outdated requirements and gaps concerning current practices, international norms and other standards. The regulations are often inflexible to innovation and may be challenging for regulated parties to navigate.
  • Action: Health Canada plans to simplify the regulatory framework for certain drugs and foods. This would involve streamlining authorization processes, addressing outdated and redundant requirements, increasing clarity, improving international alignment, and introducing flexibility and responsiveness to science and innovation.
  • Expected outcomes: The amendments should improve predictability and minimize interactions for regulated parties. They would also help introduce new and innovative products onto the Canadian market.
  • Timeline: Long-term: To be completed in 2-plus years. Health Canada expects to publish a regulatory proposal to in the Canada Gazette, Part I for consultation within 3 years.
Addressing stakeholder-identified health product and food regulatory burdens to support faster drug and food approvals
  • Context: Stakeholders have identified existing regulations and administrative processes that can be improved. These include areas such as redundant reporting obligations, paper-based processes, and outdated and unclear regulatory requirements. These can create inefficiencies, increase compliance costs, stifle innovation and cause misalignment with international standards, all increasing the time required to submit and review applications to Health Canada.
  • Action: Health Canada plans to make the regulations for human drugs and foods more flexible by introducing a risk-based approach. For example, this could be accomplished by introducing flexibilities through updated guidance and regulations. This would also allow certain data to be submitted during a drug review, streamline drug labelling (including eliminating the need for certain package inserts), and make the food pre-approval processes more efficient. Health Canada also plans to remove certain requirements, such as those for medical devices and veterinary drugs. Industry would no longer need to report on missing information related to adverse drug reaction reports already in the Canada Vigilance online database, which gives public access to information about reported adverse drug reactions. The department would also reduce the scope of the Public Release of Clinical Information application for medical devices to focus only on key areas of public interest.

    Health Canada also plans to modernize processes, guidance and regulatory requirements. This includes introducing flexibilities for certain food and nutrition requirements, and updating the rules for how different medical devices are classified. The department also plans to implement a record retention period for product safety information that is harmonized and based on the product's risk level.

  • Expected outcomes: Making it easier for industry to meet regulatory requirements and reducing administrative burden will encourage better industry compliance. Regulated parties would be able to focus on product development rather than navigating complex processes, reporting obligations or licence renewals. Modernizing regulations and processes that align requirements, classifications and processes with international standards and practices would also enable stakeholders to adopt new technologies and respond to market needs more effectively. This increased process efficiency and modernized regulations are expected to also support faster drug approvals.
  • Timeline: Long-term: To be completed in 2-plus years. Health Canada expects to pre-publish the regulatory proposal in the Canada Gazette, Part I for consultation in 2027.
Repealing and replacing the Quarantine Regulations
  • Context: The Quarantine Act and Quarantine Regulations serve to prevent the introduction and spread of communicable diseases. The act and regulations have been updated a few times, making some of their reporting requirements redundant. For example, when section 34 of the act came into force in 2007, the reporting requirements in sections 12 and 19 of the regulations became redundant.
  • Action: The Public Health Agency of Canada plans to repeal and replace sections 12 and 19 of the Quarantine Regulations that duplicate reporting requirements found in section 34 of the act. The agency also plans to clarify the reporting requirements for conveyance operators (for example, boats or aircrafts), which help to prevent the introduction and spread of communicable diseases.
  • Expected outcomes: Repealing and replacing these 2 sections of the Quarantine Regulations will remove redundant reporting requirements and clarify the reporting obligations. These changes would reduce administrative burden and make the requirements clearer for conveyance operators, thus encouraging compliance and helping to ensure public safety.
  • Timeline: Medium-term: To be completed in 2 years. A Canada Gazette, Part I, consultation on the proposed amendments is expected in 2026.
Amending the schedule to the Quarantine Act
  • Context: The schedule in the Quarantine Act lists specific communicable diseases that are subject to certain requirements under the act. The act gives the Minister of Health the power to identify and manage communicable diseases that could threaten public health. Currently, the schedule lists each disease instead of using broader categories, which makes it harder to respond quickly to emerging or changing public health threats. This creates challenges for both the Public Health Agency of Canada and regulated parties.
  • Action: The Public Health Agency of Canada plans to group the list of diseases in the schedule into broader, more flexible categories instead of listing each disease.
  • Expected outcomes: Revising the schedule to the Quarantine Act would simplify regulatory requirements and minimize the need to update the act every time the disease list changes. It would reduce administrative burden for travellers and conveyance operators and simplify the reporting process.
  • Timeline: Medium-term: To be completed in 2 years. A Canada Gazette, Part I consultation on the proposed amendments is expected in 2026.

Theme 5: Enabling new products and technologies

Progress achieved

Amending certain regulations made under the Food and Drugs Act (agile licensing)
  • Context: The pace of innovation today means that drugs and medical devices regulated by Health Canada have been evolving more rapidly than the regulatory frameworks that were designed to manage them. Regulatory amendments were required to provide a legal framework that more effectively supports existing policy practices and strengthens the safety oversight of drugs and medical devices throughout their lifecycle.
  • Action: Health Canada delivered on its commitment to modernize the regulations by amending the Food and Drug Regulations. The department repealed outdated, product-specific requirements for biologic drugs. Extended flexibilities, such as rolling submissions for drug approvals during a public health emergency, were also introduced, which allow drug-related information to be submitted and reviewed as it becomes available. The department also updated the requirements for drug standards and labelling of biologic drugs.
  • Expected outcomes: Replacing product-specific requirements for biologics helps better address advancements in science and technology, and product innovation. The amendments also facilitate access to public health emergency drugs through the adoption of rolling reviews. Finally, requirements related to drug standards were updated to address concerns from manufacturers that previous requirements were not necessary to ensure the safety, effectiveness and quality of certain drugs. This has decreased the administrative burden for businesses. The decrease is estimated at $33,000 (or $24,000 in 2012 dollars per the Regulatory Impact Analysis Statement requirements), or $2,200 ($1,600 in 2012 dollars) per business.
Enabling software as a medical device
  • Context: Software plays an increasingly important role in the health care sector, with machine learning-enabled medical devices (MLMDs) being adopted to enhance diagnosis, treatment and efficiency of the health care system.
  • Action: Health Canada finalized the Pre-Market Guidance for Machine-Learning Enabled Medical Devices in February 2025. It provides guidance to medical device manufacturers on how to demonstrate the safety and effectiveness of an MLMD for the purposes of applying for a medical device licence. The guidance also sets out expectations for developing a predetermined change control plan. This process lets Health Canada authorize planned changes to a medical device in advance, without needing another review.

    Health Canada developed the guidance using a risk-based approach, focusing on the evidence manufacturers can use to demonstrate an MLMD's safety and effectiveness. The department also adopted MLMD terms and definitions used by the International Medical Device Regulators Forum, which have also been adopted by other international regulators. The guidance document encourages manufacturers to consider performance monitoring to detect degradation of their devices and emerging risks. It also encourages manufacturers to adopt mandatory risk management updates for artificial intelligence (AI) models that evolve over time.

  • Expected outcomes: The guidance helps manufacturers navigate the medical device licence application process and reduces barriers for the introduction of new medical device technologies. It also supports rapid innovation cycles of AI-based medical devices while ensuring they are safe and effective. As well, adopting international definitions for MLMDs will create better alignment with other regulatory partners.

Ongoing and future initiatives

Modernize the New Substances Notification Regulations (Organisms) and New Substances Notification Regulations (Chemicals and Polymers) (co-led by ECCC)
  • Context: In Canada, industry needs to follow regulatory requirements to bring new substances into the marketplace. These new substances include chemicals, polymers and genetically modified or other living organisms. However, some of these requirements do not reflect recent advances in science and technology. This can create barriers to innovation.
  • Action: Together with Environment and Climate Change Canada (ECCC), Health Canada plans to engage with industry to amend the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). The proposed amendments would help reduce barriers to entry into the Canadian market by addressing inefficiencies and better capture advances in science and technology.
  • Expected outcomes: Amending the regulations would help industry by streamlining requirements, so that people in Canada can get quicker access to safe modern products such as innovative medicines. By updating how Health Canada and Environment and Climate Change Canada assess new substances, the departments will be able to respond to businesses more quickly, while continuing to protect people and the environment. Allowing alternative test data for new chemicals would also reduce reliance on animal testing. This would also reduce barriers for businesses, as alternatives to animal testing are often cheaper and faster to generate data.
  • Timeline: Long-term: To be completed in 2-plus years. Upcoming milestones include stakeholder consultations on proposed amendments to the New Substances Notification Regulations (Chemicals and Polymers) and the publication of proposed amendments in the Canada Gazette, Part I for both regulations.
Modernizing the framework for clinical trials
  • Context: Rapid change in the clinical trial environment, combined with the current one-size-fits-all regulatory framework, is causing unnecessary red tape. This hinders the research community's ability to undertake innovative clinical trials in Canada and for patients to benefit from new technologies.
  • Action: Health Canada is drafting regulations to modernize the framework for clinical trials for drugs and developing associated draft guidance. The regulations would establish appropriate requirements for certain trials based on risk. The regulations would also authorize clinical trial products for new trial types and designs. Once draft regulations are published, a public consultation period will follow.

    Future phases of modernization would bring bolder innovation to the clinical trials environment. Possible future actions include allowing multiple product lines under a single authorization and increasing foreign regulatory collaboration.

  • Expected outcomes: The actions are expected to result in a more modern and flexible regulatory framework for clinical trials that is proportionate to risk. The modernization will encourage clinical trials to be conducted in Canada and help increase access to novel therapies.
  • Timeline: Medium-term: To be completed in 1 year. Health Canada expects to pre-publish the regulatory proposal in the Canada Gazette, Part I for consultation in 2026.

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