Health Canada’s Forward Regulatory Plan: 2025-2027

Enabling act:

Canada Consumer Product Safety Act

Description:

We are proposing to repeal the Matches Regulations to remove outdated testing and labelling requirements.  

The regulations also prohibit matches that contain any white phosphorus, which is highly toxic. While white phosphorus is no longer used to manufacture matches, protections from this substance could be maintained through provisions available under the Canada Consumer Product Safety Act.

We identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential Impacts:

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. 

Consultations:

A notice of intent to repeal the regulations was published as part of Health Canada and the Public Health Agency of Canada’s red tape review.

The repeal is to be completed in 2 years. The department will explore whether these amendments can be made as part of an omnibus approach to streamline the timelines.

People in Canada will have an opportunity to provide comments on the proposed regulatory amendments during the Canada Gazette, Part I, public comment period.

For more information, contact:

Geoff Barrett
Director
Risk Management Bureau
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
343-542-3045
Email: ccpsa-lcspc@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Canada Consumer Product Safety Act

Description:

We are proposing to amend requirements in the Toys Regulations to better protect children from chemical and toxicological hazards when they play with toys.

Where alternative methods exist, we are proposing to reduce (or eliminate, where possible) the need for animal testing to determine compliance with the chemical and toxicological requirements in the regulations.

The amendments would address some of the existing requirements that are obsolete or need to be updated.

The proposed amendments would also add new requirements for hazards that are not presently addressed by the regulations, such as requirements for:

• finger paints
• certain harmful elements where they are accessible to a child
• liquids, pastes, putties, gels, powders and items originating from avian feathers

We propose to align the requirements with existing international toy safety standards, where appropriate.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

The proposal would align some of Canada's requirements with those established by several countries, including the United States, European Union, Australia , New Zealand, Indonesia, India, Malaysia, South Africa and Vietnam.

Potential impacts:

The stakeholder groups affected by these amendments are industry and consumers.

These proposed regulations would add new safety requirements for toys sold in Canada, which would better protect Canadian consumers. We anticipate there will be initial costs to suppliers who may need to re-evaluate their products to ensure that they comply with the new requirements.

The amendments are expected to better align our requirements with those in other countries, and thus reduce testing costs for industry and facilitate international trade.

These changes improve animal welfare as there would be reduced reliance on animal testing.

Consultations:

We published a notice of intent to interested parties in June 2023, followed by a 90-day public comment period.

People in Canada were invited to comment on the proposed changes to the regulations. A total of 12 stakeholders provided feedback and included:

• industry stakeholders
• regulatory consultants
• governmental organizations
• members of the public
• consumer interest groups

Most stakeholders supported the proposal to:

• amend the toxicity, corrosivity, irritation and sensitization requirements, to either reduce or eliminate animal testing for toys
• add extra safety requirements for fingerpaints, microbiological contamination of certain toys and chemical toys (sets) other than experimental sets

Most stakeholders also believed that additional requirements should align with international toy safety standards, to reduce technical barriers to trade.

People in Canada will have an opportunity to once again provide comments on the proposed regulatory amendments during the Canada Gazette, Part I, public comment period. This is expected to take place in winter/spring 2026 and last 75 days.

Learn more:

• Toy Safety

For more information, contact:

Geoff Barrett
Director
Risk Management Bureau
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
343-542-3045
Email: ccpsa-lcspc@hc-sc.gc.ca

Date when first included in the plan: May 2024

Health Canada and Environment and Climate Change Canada (ECCC) jointly propose the following regulatory initiatives, which are under the Canadian Environmental Protection Act, 1999:

• Reduction in the Release of Volatile Organic Compounds (Storage and Loading of Volatile Petroleum Liquids) Regulations
• Regulations Amending the Volatile Organic Compound (VOC) Concentration Limits for Architectural Coating Regulations
• Amendments to the Regulations Respecting Reduction in the Release of Methane and Certain Volatile Organic Compounds (Upstream Oil and Gas Sector)
• Regulations Repealing the Secondary Lead Smelter Release Regulations
• Regulations to Reduce Landfill Methane Emissions
• Regulations for an Oil and Gas Sector Greenhouse Gas Emissions Cap
• Amendments to the Multi-Sector Air Pollutants Regulations Part 1: Boilers and Heaters (low impact) for time-sensitive amendments to Part 1 only
• Broader Amendments to the Multi-Sector Air Pollutants Regulations (MSAPR) Part 1: Boilers and Heaters and Part 2: Stationary Spark-ignition Engines
• Regulations Amending the Chromium Electroplating, Chromium Anodizing, and Reverse Etching Regulations
• Regulations Amending the New Substances Notification Regulations (Organisms)
• Prohibition of Certain Toxic Substances Regulations, 2024
• Order Amending the Export Control List in Schedule 3 to the Canadian Environmental Protection Act, 1999
• Recycled Content and Labelling for Plastic and Single-Use Items Regulations
• Regulations Amending the PCB Regulations
• Certain Products Containing Toxic Substances Regulations
• Regulations Amending the New Substances Notification Regulations (Chemicals and Polymers)
• Orders Adding Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999

Learn more:

• ECCC Forward Regulatory Plan

For more information, contact:

Andrew Beck
Director
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
613-266-3591
Email: formaldehyde-formaldehyde@hc-sc.gc.ca

Enabling act:

Cannabis Act

Description:

We are proposing to amend the Cannabis Tracking System Order to reduce regulatory burden while continuing to track the high-level movement of cannabis through the supply chain as a means of preventing the diversion of cannabis to the illegal market or its inversion into the legal market. The proposed amendments would simplify reporting by limiting reporting to information essential for tracking the movement of cannabis.

We identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The proposed amendments would reduce the overall regulatory burden on regulated parties, while continuing to support the objectives of the Cannabis Tracking System Order.

Stakeholders that may be impacted by these proposed amendments are licence holders under the Cannabis Act and provinces and territories.

Consultations:

We published a notice of intent on August 30, 2025, followed by a 60-day public comment period.

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in fall 2026.

For more information, contact:

Andrea Budgell
Director
Regulatory, Legislative and Economic Affairs Division
Strategic Policy (Cannabis)
Controlled Substances and Cannabis Branch
613-302-6228
Email: cannabis.consultation@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Controlled Drugs and Substances Act

Description:

Canada's regulatory framework for controlled substances has evolved over decades to address emerging issues. This has resulted in a set of regulations that, while containing broadly similar provisions, also feature challenges, gaps and inconsistencies for regulated parties and the regulator.

We are proposing to consolidate the following regulations into 1 new modern regulation for controlled substances:

• Narcotic Control Regulations
• Benzodiazepines and Other Targeted Substances Regulations
• Parts G and J of the Food and Drug Regulations
• New Classes of Practitioners Regulations

We are also proposing to repeal the Regulations Exempting Certain Precursors and Controlled Substances from the Application of the Controlled Drugs and Substances Act.

Provisions for licences and permits were modernized in 2019. As part of the proposed regulations, we are proposing changes to the regulatory provisions for pharmacists, individuals, and destruction and test kits to:

• support pharmacy innovation in Canada
• maintain stewardship over the movement of controlled substances
• allow people to travel internationally with prescription drugs containing controlled substances for personal medical use and return prescription drugs containing controlled substances to a pharmacy for disposal
• allow pharmacists, pharmacy technicians, practitioners and persons in charge of a hospital to destroy controlled substances or provide them to licensed dealers for the purpose of destruction
• update the provisions for test kits

We are also proposing to make changes to other federal regulations, such as the Precursor Control Regulations, Cannabis Regulations and Food and Drug Regulations.

We identified this initiative in the Health and Biosciences Sector Regulatory Review Roadmap and Health Canada's Regulatory Stock Review Plan.

We also identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The proposed modernized and consolidated regulations would:

• support pharmacy innovation in Canada
• improve clarity and consistency
• improve the administration of and compliance with the regulations

Stakeholders that may be impacted by the proposal include pharmacies, pharmacists and pharmacy technicians, licensed dealers, patients and health care providers.

Consultations:

We pre-published the proposed Controlled Substances Regulations in the Canada Gazette, Part I, on June 1, 2024. People in Canada had the opportunity to comment on the regulatory proposal during the 60-day public comment period. We considered the feedback received from stakeholders when finalizing the regulations, which will be published in the Canada Gazette, Part II. This is expected to take place in fall 2025.

We are also considering further modernization of the provisions for hospitals and practitioners in these regulations. We published a notice of intent on June 1, 2024, to initiate consultations with provinces, territories, and stakeholders. The outcome of these consultations will inform future regulatory changes.

For more information, contact:

Jennifer Pelley
Director
Office of Legislative and Regulatory Affairs
Controlled Substances and Overdose Response Directorate
Controlled Substances and Cannabis Branch
613-410-1829
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca

Date when first included in the plan: April 2021

Enabling act:

Controlled Drugs and Substances Act

Description:

We are proposing amendments to Schedule VI and IV of the Controlled Drugs and Substances Act to allow for longer-term controls over 5 fentanyl precursors and the drug carisoprodol.

All known essential building blocks that can be used to produce fentanyl are controlled in Canada. Although it is not possible to produce fentanyl without using one of the already controlled building blocks, other chemicals can also be used in the illegal production of fentanyl.

These chemicals include:

• phenethyl bromide
• propionic anhydride (also known as propanoyl propanoate)
• benzyl chloride

These precursors and the drug carisoprodol are currently subject to temporary controls though a ministerial order signed by the former Minister of Mental Health and Addictions and Associate Minister of Health on February 27, 2025. As this ministerial order is only in effect for one year, we are proposing to move forward with longer-term controls.

Evidence shows that phenethyl chloride and phenethyl iodide can easily replace phenethyl bromide in the illegal production of fentanyl. To address this, we are also proposing to regulate these two substances.

Regulatory amendments will add all 5 fentanyl precursors to Schedule VI of the Controlled Drugs and Substances Act and add carisoprodol to Schedule IV of the Act.

They will also regulate:

• phenethyl bromide, phenethyl chloride, phenethyl iodide, and propionic anhydride as Class A precursors under the Precursor Control Regulations
• benzyl chloride as a Class B precursor under the Precursor Control Regulations
• carisoprodol as a targeted substance under the Benzodiazepines and Other Targeted Substances Regulations

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

The proposal would better align Canada with international drug conventions, to which Canada is a party.

Potential Impacts:

Controls for these substances will help disrupt the production and supply of illegal drugs, both in Canada and internationally. Under the Controlled Drugs and Substances Act, possession, production, trafficking, importation, etc., are prohibited unless you have an appropriate authorization from Health Canada. Anyone who wants to conduct otherwise prohibited activities with these fentanyl precursor chemicals and the drug carisoprodol will have to apply to the Department for a licence or registration.

Consultations:

We published a notice of intent on February 14, 2025, followed by a 10-day public comment period.

Ministerial orders signed on February 27, 2025, introduced temporary controls. These controls took effect in April 2025 for phenethyl bromide and carisoprodol, and in May 2025 for propionic anhydride and benzyl chloride. Industry was given an opportunity to provide information about the impact of the proposed controls.

Final regulations for carisoprodol were published in the Canada Gazette, Part II, in November 2025.

We plan to publish final regulations for the 5 fentanyl precursors in the Canada Gazette, Part II, by spring 2026. This will establish longer-term controls for these substances before the temporary controls expire.

For more information, contact:

Jennifer Pelley
Director
Office of Legislative and Regulatory Affairs
Controlled Substances and Overdose Response Directorate
Controlled Substances and Cannabis Branch
613-410-1829
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Controlled Drugs and Substances Act

Description:

We are bringing forward new tools to support law and border enforcement in their efforts to address the illegal importation of precursor chemicals and the illegal importation, production, and trafficking of fentanyl and other synthetic drugs by organized crime groups. Through Canada’s Border Plan, we are increasing support to law enforcement agencies to detect, intercept and address fentanyl and precursor chemicals.

We are proposing  amendments to the regulations for precursor chemicals and drug equipment to:

• require licensed and registered companies to report suspicious transactions with precursors to Health Canada
• require licensed and registered companies to take reasonable steps to minimize risks of their employees diverting precursors to the illegal market
• add condition-of-sale restrictions for ephedrine and pseudoephedrine – precursors used to produce methamphetamine
• expand registration requirements for certain designated drug equipment (pill presses and capsule filling machines) that can be used in the illegal production of drugs, to include certain key component parts
• introduce new regulatory flexibilities for Health Canada to respond quickly to public health and public safety risks

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The proposed amendments would provide law and border enforcement and the Government of Canada with additional tools to address public health and public safety risks of precursor chemicals and drug equipment that can be used by illegal drug producers.

The proposed amendments would also impact companies with a licence or registration that allows them to legally conduct certain activities with precursor chemicals, as well as anyone legally importing certain drug equipment into Canada.

Consultations:

We pre-published the proposed regulatory changes in the Canada Gazette, Part I, on June 28, 2025, followed by a 45-day public comment period.

We considered the feedback received from stakeholders when finalizing the regulations, which will be published in the Canada Gazette, Part II. This is expected to take place in fall 2025.

We intend to repeal the Ministerial Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine once the proposed regulations take effect, to avoid duplicating condition of sale restrictions for these products.

For more information, contact:

Jennifer Pelley 
Director 
Office of Legislative and Regulatory Affairs 
Controlled Substances and Overdose Response Directorate 
Controlled Substances and Cannabis Branch 
613-410-1829 
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Food and Drugs Act

Description:

We are proposing to take a comprehensive approach to modernizing Divisions 24 and 25, Part B of the Food and Drug Regulations. These sections govern foods for special dietary use (FSDU) and foods for infants in Canada.

This regulatory modernization proposal would:

• reflect and adapt to advances in nutritional science
• promote a diverse market to reduce the risk of shortages
• support increased innovation
• improve alignment with international jurisdictions
• improve access to these critical nutrition products for people in Canada
• reduce barriers to importing these foods into Canada

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

This regulatory proposal would better align Canada's requirements with those of other jurisdictions, where appropriate.

Potential impacts:

The proposed amendments would apply to businesses that sell or advertise regulated food products in Canada.

The proposal would provide greater clarity and predictability for businesses and allow them to bring food products to market in a timely manner. People in Canada would benefit from greater access to safe and innovative food products.

Consultations:

We announced this initiative in a notice to stakeholders in spring 2023. We sought feedback from interested parties, by issuing a pre-consultation paper outlining our proposal to modernize the regulatory framework for FSDU and foods for infants in fall 2023. We also consulted on compositional requirements in fall 2024.

People in Canada will have an opportunity to comment on the regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in spring 2027.

Learn more:

• Notice to Stakeholders: Health Canada's strategy to manage shortages of infant formula and other foods for a special dietary purpose and to modernize related regulations
• Regulatory modernization of foods for special dietary use and infant foods: Divisions 24 and 25 of the Food and Drug Regulations
• Proposed compositional requirements for infant foods and foods currently regulated as foods for special dietary use

For more information, contact:

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date when first included in the plan: May 2024

Enabling act:

Food and Drugs Act

Description:

We are proposing to make a ministerial exemption order to help ensure continued access to naloxone kits on the Canadian market, while maintaining the quality, safety, efficacy and traceability of these kits.

The exemption order would replace Health Canada’s Interim policy on the packaging, labelling and sale of naloxone kits and provide flexibility and transparency on the Department’s approach to addressing the unlicensed assembly and sale of naloxone kits.

The order will include exemptions from certain provisions of the Food and Drug Regulations, the Medical Devices Regulations, and the Natural Health Products Regulations under certain conditions. These exemptions may include requirements related to product authorizations and establishment or site licences, as some stakeholders may not be able to meet all current regulatory requirements. The conditions would focus on the quality, safety, efficacy, and traceability of these kits in Canada, which are key to mitigating possible health and safety risks to people in Canada.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential Impacts:

The order is expected to enable the continued supply and distribution of naloxone on the Canadian market to respond to the opioid crisis.

Consultations:

We have been engaging with provinces and territories to learn about their activities related to naloxone kits, how they relate to existing federal regulations, and to assess if there are associated health and safety risks.

In March 2025, a notice of intent was published in Canada Gazette, Part I. Targeted stakeholder consultation sessions were held on the proposed exemption order, including with provincial and territorial representatives, pharmacy groups, and industry members. Feedback supported the proposed approach to extend the flexibilities outlined in the interim policy through the order.

For more information, contact:

Jillian Andrews
A/Associate Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
343-553-1188
Email: prsd-questionsdspr@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Food and Drugs Act

Description:

We are proposing to amend the Natural Health Products Regulations to reduce regulatory burden for both industry and government, while maintaining a level of oversight that is proportionate to both risk and uncertainty. We plan to introduce a registration process for certain natural health products (NHPs), along with flexible risk-based safety monitoring for all NHPs. We also plan to amend the regulations by making labelling requirements more flexible and reducing authorization requirements in areas where oversight is more appropriate after the product is authorized.

We identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation plan.

This regulatory proposal would better align Canada's requirements with those of other jurisdictions, such as the U.S., European Union and Australia where appropriate given international models for the regulation of NHPs vary significantly.

Potential Impacts:

The proposed amendments would apply to businesses involved in selling natural health products in Canada. The regulatory proposal would simplify both application requirements and post-authorization obligations for NHPs. Industry would have more flexibility to meet their obligations. This proposal would also encourage more products to be brought to the Canadian market.

Consultations:

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I, public comment period. This is expected to take place in spring 2027.

For more information, contact:

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Food and Drugs Act

Description:

We are proposing to amend the Food and Drug Regulations to introduce modern, flexible regulations for non-prescription drugs (NPDs) with simplified requirements appropriate for these products to fast-track their approval. We plan to introduce a registration process for certain NPDs, along with flexible risk-based safety monitoring for all NPDs. This proposal aims to reduce regulatory burden for both industry and government, harmonize with international requirements where possible, while maintaining consumer safety and access.

We identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation plan.

This regulatory proposal would strive to better align Canada's requirements with those of other jurisdictions, such as the U.S., European Union and Australia, where possible.

Potential Impacts:

The proposed amendments would apply to businesses involved in selling non-prescription drugs in Canada. The regulatory proposal would simplify both application requirements and post-authorization obligations for NPDs. Industry would have more predictability and flexibility to meet their obligations. This proposal would also encourage more products to be brought to the Canadian market. People in Canada would gain faster access to a greater variety of safe and effective non-prescription drugs, giving them more options to maintain and improve their health.

Consultations:

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I, public comment period. This is expected to take place in fall 2026.

For more information, contact:

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Food and Drugs Act

Description:

We are proposing to make a ministerial class order under the Food and Drugs Act that would target certain classes of products approved for use by other regulatory authorities, as well as collaborative evaluations with another regulatory partner. This order would deem that certain requirements of the Food and Drug Regulations are met on the basis of the product’s authorisation for sale, or technical evaluation in the case of a joint-review, by specific foreign regulatory authorities identified under the order.

We identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation plan.

Potential Impacts:

The proposed order would apply to submissions and supplements for classes of products identified under the order where the same product has been authorised for sale by identified foreign regulatory authorities. For these submissions, it would reduce burden on regulated parties and the department, while continuing to support the public health and public safety objectives of the Food and Drugs Act.

Consultations:

Stakeholders will be engaged prior to bringing forward this instrument.

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I, public comment period. This is expected to take place in fall 2025.

For more information, contact:

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
613-321-4235 Email: lrm.consultations-mlr@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Food and Drugs Act

Description:

We are planning to simplify Part C of the Food and Drug Regulations by streamlining authorization processes, clarifying requirements and improving international alignment.

We identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation plan.

Potential Impacts:

Simplifying Part C of the Food and Drugs Regulations would improve predictability for regulated parties and facilitate the introduction of new and innovative products onto the Canadian market.

Consultations:

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I, public comment period. This is expected to take place in fall 2026.

For more information, contact:

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Food and Drugs Act

Description:

We are proposing to amend the Food and Drug Regulations to create a new framework that would modernize the regulation of clinical trials conducted in Canada that involve drugs.

The proposed framework would:

• help ensure that Canada remains an attractive place to conduct clinical trials while continuing to uphold high standards for protecting the health and safety of participants
• introduce a coherent risk-based approach to the regulation of clinical trials in Canada
• afford greater flexibility in the safe development of innovative therapies and products and innovative clinical trial designs
• align with international best practices on clinical trial oversight and public access to information

We will complete this regulatory initiative in multiple phases. The first phase would focus on the creation of a framework related to drugs. It is anticipated that future work will examine potential further burden reduction and regulatory agilities as well as the feasibility of bringing additional product lines under the new framework.

We identified this regulatory initiative in the Health and Biosciences Sector Regulatory Review Roadmap and Health Canada's Regulatory Stock Review Plan.

We also identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

This regulatory proposal would better align Canada's requirements with those of other jurisdictions, such as the U.S. and European Union.

Potential impacts:

The proposed framework for the first phase would apply to health and biosciences stakeholders involved in the conduct of drug clinical trials in Canada.

This regulatory proposal would make the regulation of clinical trials clearer, more predictable and more transparent for businesses, academics and people in Canada.

A more flexible regulatory framework would benefit researchers and industry by better accommodating innovative, non-conventional clinical trial designs. This would improve access to clinical trials. A risk-based approach would help reduce the regulatory burden for some clinical trials conducted on marketed products. Other benefits would include, for example, improved safety monitoring for participants in clinical trials in Canada.

Consultations:

We consulted stakeholders in 2019.

We also consulted stakeholders in 2020 about the Interim Order Respecting Clinical Trials for Medical Devices and Drugs relating to COVID-19. This interim order has similar regulatory approaches to those in this proposal.

In spring 2021, we held 2 related and parallel consultations with stakeholders to seek feedback on:

• modernizing the clinical trial framework for drugs, devices and natural health products
• designing and developing regulations for authorizing and conducting human clinical trials in Canada on foods for a special dietary purpose

In winter and spring 2023, we sought feedback on the registration of clinical trials and public disclosure of results.

Interested parties will have the opportunity to comment on the regulatory proposal to modernize the clinical trial framework for drugs (first phase). The Canada Gazette, Part I public comment period is expected to take place in fall 2025.

Learn more:

• Regulatory innovation for health products: Modernizing clinical trial regulations
• Agile regulations for advanced therapeutic products and clinical trials
• Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
• Clinical trials modernization: Consultation paper
• Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations

For more information, contact:

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date when first included in the plan: June 2019

Enabling act:

Food and Drugs Act

Description:

We are proposing a second phase (Phase 2) of regulatory amendments to the Medical Devices Regulations (MDR). The first phase of amendments, Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing), was published in Canada Gazette, Part II on July 3, 2024. Phase 2 of the amendments would continue the commitments to modernize compliance and enforcement oversight of medical device establishment licences.

The proposed regulatory amendments would:

• exempt foreign distributors from holding a medical device establishment license  (MDEL) if they are selling their medical devices through Canadian distributors already holding an MDEL
• provide certainty regarding the expectation that MDEL holders need to establish, implement, and maintain documented procedures
• require all MDEL applicants and licence holders to provide a supplier list of "persons" selling into and within Canada

We identified this regulatory initiative in the Health and Biosciences Sector Regulatory Review Roadmap and Health Canada's Regulatory Stock Review Plan.

We also identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

The Phase 2 amendments would align registration requirements in Canada with the United States by reducing redundancies in licensing. This would allow the department to have better insight into the foreign supply chain and work to enhance transparency to align with the World Health Organization’s best practices.

These proposed amendments would increase international harmonization while protecting the health and safety of people in Canada.

Potential impacts:

Phase 2 would reduce burden for industry and clarify existing regulatory requirements, while still maintaining sufficient oversight to protect the health and safety of people in Canada.

These amendments would improve international alignment and enhance the line of sight on medical devices being imported into Canada. The amendments would also benefit the health of people in Canada who use or may use medical devices.

Consultations:

In fall 2024, we published a notice of intent in the Canada Gazette, Part I, followed by a 30-day comment period. Overall, stakeholders were in support of the proposal and reiterated their desire for clear and modern regulatory requirements for medical device establishment licensing.

People in Canada will also have an opportunity to comment on the Phase 2 regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in fall 2025 and last 70 days.

Learn more:

• Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)

For more information, contact:

Jillian Andrews
A/Associate Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
343-553-1188
Email: prsd-questionsdspr@hc-sc.gc.ca

Date when first included in the plan: February 2021

       

Enabling act:

Food and Drugs Act

Description:

We are proposing a second phase (Phase 2) of regulatory amendments to the Food and Drug Regulations (FDR). The first phase of amendments, Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing), was published in Canada Gazette, Part II on July 3, 2024. Phase 2 of the amendments would continue the commitments to modernize compliance and enforcement oversight of drug establishment licences.

The proposed amendments would:

• reduce the burden associated with annual licence review
• modernize the provisions related to using compliance and enforcement tools, such as terms and conditions and suspensions
• introduce less prescriptive and more flexible provisions that would maintain appropriate oversight of regulated activities conducted in Canada, while continuing to support the health and safety of people in Canada

We identified this regulatory initiative in the Health and Biosciences Sector Regulatory Review Roadmap. It is also associated with Health Canada's Regulatory Stock Review Plan.

We also identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

Phase 2 amendments would reduce the regulatory burden on industry by leveraging partnerships with international regulators.

Potential impacts:

Phase 2 amendments would reduce administrative burden on industry stakeholders and set out a more streamlined, risk-based approach to the issuance, refusal and suspension of establishment licences.

Consultations:

We have consulted with stakeholders since 2018 on both phases of DEL modernization.

People in Canada will have an opportunity to comment on the regulatory proposal for Phase 2 during the Canada Gazette, Part I public comment period. This is expected to take place in fall 2026/winter 2027 and last 75 days.

Learn more:

• Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)

For more information, contact:

Jillian Andrews
A/Associate Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
343-553-1188
Email: prsd-questionsdspr@hc-sc.gc.ca

Date when first included in the plan: February 2021

Enabling act:

Food and Drugs Act

Description:

We are proposing to address the regulatory oversight of outsourced drug preparation activities in Canada. These activities are referred to as the non-patient specific preparation of drugs by a third party, outside of a patient–health care professional relationship.

The regulatory proposal would build upon existing frameworks within the Food and Drug Regulations.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

The proposal would consider existing provincial and territorial regulatory regimes and approaches by other foreign regulators that govern outsourced drug preparation activities.

Potential impacts:

The proposal would increase regulatory certainty and oversight on outsourced drug preparation in Canada.

Consultations:

We gathered information from provincial and territorial pharmacy regulatory authorities in 2019, 2021, 2023, and 2024, as well as provincial and territorial ministries of health in 2023. In 2024, we also gathered information from foreign regulators to understand other jurisdictions’ approaches to outsourced drug preparation. 

We plan to consult provinces, territories and other stakeholders before we pre-publish the proposal in the Canada Gazette, Part I.

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in fall 2026 and last 75 days.

Learn more:

• Policy on manufacturing and compounding drug products in Canada (POL-0051)

For more information, contact:

Jillian Andrews
A/Associate Director
Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
343-553-1188
Email: prsd-questionsdspr@hc-sc.gc.ca

Date when first included in the plan: October 2014

Enabling act:

Food and Drugs Act

We are proposing to amend the Food and Drug Regulations, the Medical Devices Regulations, and the associated guidance documents to better protect people in Canada from the harms of health product shortages.

These proposed amendments will help us:

• focus on new tools to respond to shortages and amend existing frameworks to address shortages more efficiently
• further mitigate safety risks related to using non-compliant products to address a shortage

This initiative is a commitment in the Minister of Health's December 2021 Mandate Letter to strengthen medical supply chains. It builds on the commitment made in 2019 to take action with manufacturers, provinces and territories, and other stakeholders to address drug shortages.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation workplan.

The proposed amendments consider existing provincial and territorial regulatory regimes and approaches taken by other foreign regulators that use regulatory tools to address drug and medical device shortages.

Potential impacts:

The proposed amendments apply to businesses involved in the sale of drugs and medical devices in Canada.

This regulatory proposal will :

• reduce the likelihood that people in Canada are harmed by drug and medical device shortages
• provide the department with better tools to mitigate health product shortages

Some increased burden may be imposed related to improving the oversight of products that are exceptionally imported and sold to help prevent and mitigate shortages. However, we expect that companies will also experience greater efficiencies from improved reporting and exceptional importation frameworks.

Consultations:

Stakeholder engagement and consultation is ongoing. We have engaged with:

• industry stakeholders
• health care professionals and associations
• provincial and territorial governments
• other government departments
• patient and advocacy groups
• Indigenous groups
• Academia
• members of the public

We held public consultations from June to August 2023 to identify challenges and solutions to improve access to drugs and other health products in Canada. We published a what we heard report in December 2023, summarizing stakeholder feedback on 4 key action areas:

• improved communication and transparency
• agile regulatory toolbox
• greater supply chain visibility
• enhanced response to supply and demand

We also held an open consultation on this regulatory proposal and sought feedback from industry stakeholders between June 25 and July 25, 2024.

We published the proposed changes in the Canada Gazette, Part I, on December 28, 2024, followed by a 70-day public comment period.

We received comments on the regulatory proposal from December 28, 2024, to March 8, 2025, through the Online Regulatory Consultation System. We also held two technical briefing sessions on the regulatory proposal that focused on the respective amendments to the Food and Drug Regulations and the Medical Devices Regulations.

As we work to refine policies, regulations and programs, we will continue to seek feedback on how to better mitigate and prevent the shortages of drugs and other health products in an increasingly complex environment.

We plan to publish the amended regulation in the Canada Gazette, Part II, in spring 2026.

Learn more:

• Consultation page on proposed amendments to regulations to address health product shortages in Canada
• Building resilience: Health Canada's plan to address health product shortages, 2024 to 2028
• Notice of intent to amend the regulations to address health product shortages in Canada
• What we heard: Improving access to drugs and other health products in Canada
• Drug shortages in Canada

For more information, contact:

Cynthia Colapinto
Director
Policy and Data Division
Health Product Shortages Directorate
Regulatory Operations and Enforcement Branch
613-462-8871
Email: hpsdpdcorr-corrdgppsdp@hc-sc.gc.ca

Date when first included in the plan: May 2024

Enabling act:

Food and Drugs Act

Description:

We are proposing to make a ministerial class exemption order under the Food and Drugs Act, to replace the interim policy on the importation and sale of infant formulas, human milk fortifiers and dietary products for the treatment of inborn errors of metabolism to mitigate shortages. This interim policy has been in place since March 2022 and will expire on December 31, 2025.

The order will:

• enable the importation and/or sale of certain non-compliant foods for a special dietary purpose by exempting them, subject to conditions, from provisions of the Food and Drugs Act and the Food and Drug Regulations when there is a shortage or risk of a shortage of these products
  • such foods include infant formula, human milk fortifiers and formulated liquid diets
• continue the importation and sale of infant formula and human milk fortifiers that form part of the Department’s Transition Strategy to prepare for the expiration of Health Canada's interim policy to mitigate infant formula shortages

This ministerial order is a temporary measure. It will remain in force until shortage-related regulations for foods for a special dietary purpose are introduced as part of Health Canada's regulatory modernization of foods for special dietary use and infant foods.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation plan.

The order will facilitate trade. If there is a shortage or risk of the shortage of the identified products, we will be able to access certain domestic or foreign made foods for a special dietary purpose that may not fully meet Canada's regulatory requirements but are manufactured to comparable standards.

Potential impacts:

Foods for a special dietary purpose are a critical source of energy and essential nutrients for vulnerable people. If these people are unable to access these products, their health could be seriously impacted.

The order would establish a transparent and predictable regulatory tool to maintain access to these foods in the event of a shortage or risk of a shortage.

This order will allow us to diversify and increase the Canadian supply of certain foods for a special dietary purpose affected by a shortage until the situation resolves. In this way, it will have a direct and positive impact.

Consultations:

We announced this initiative in a notice to stakeholders in fall 2024. This notice of intent was published on October 1, 2024, for a 45-day consultation. A second notice of intent was launched on June 30, 2025 and closed on August 14, 2025. Its purpose was to outline revisions made to the proposal following the initial notice of intent.

We plan to publish the order in the Canada Gazette, Part II in fall 2025.

For more information, contact:

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date when first included in the plan: October 2024

Enabling acts:

Pest Control Products Act

Description:

We are proposing regulatory amendments to the Pest Control Products Fees and Charges Regulations to establish appropriate fees and improve alignment with other regulatory programs. We last updated our fees for pesticides in 2017. The Directive on Charging and Special Financial Authorities calls for departments to periodically review the activities for which fees are charged. The current fees do not reflect the current costs for post-market regulatory activities.

The proposed amendments focus on the annual charge.

This regulatory initiative is part of Health Canada's Regulatory Stock Review Plan.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The proposed regulatory amendments would establish more appropriate sharing of costs between public and private contributions for the post-market oversight of pest control products.

Consultations:

We published a consultation document outlining our proposed amendments to the Pest Control Products Fees and Charges Regulations (Annual Charge) on January 17, 2024. The consultation period lasted 74 days.

We also undertook targeted consultations with key stakeholder groups between October 2023 and March 2024. We pre-published the proposed changes in the Canada Gazette, Part I on December 21, 2024, followed by a 75-day public comment period. We held informational webinars with key stakeholder groups and the general public. We continue to carefully consider stakeholder feedback received during CGI consultations, and as such, next steps and timing remain to be determined.

For more information, contact:

Jordan Hancey
Director
Policy and Regulatory Affairs Division
Pest Management Regulatory Agency
613-302-3886
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Date when first included in the plan: November 2023

Enabling act:

Pest Control Products Act

Description:

We are proposing to amend the Pest Control Products Regulations to:

• expand the scope of the provisions to include all research on pest control products to permit a greater range of research
• streamline and clarify certain aspects of the research provisions
• add exemptions for research on microbial agents

This regulatory initiative is part of our comprehensive review of the regulations. It is also associated with Health Canada's Regulatory Stock Review Plan.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

Some changes, like expanding permitted research and requiring pathogen authorizations, may increase administrative burden. Others, such as exemptions for microbial agent research, are expected to reduce it. On balance, the overall administrative burden is expected to decrease.

Consultations:

We held pre-consultations with stakeholders on the proposed amendments to the research provisions starting on December 16, 2022. The consultation period lasted 45 days.

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in fall 2026.

We plan to publish the amended regulations in the Canada Gazette, Part II in spring 2027.

For more information, contact:

Jordan Hancey
Director
Policy and Regulatory Affairs Division
Pest Management Regulatory Agency
613-302-3886
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Date when first included in the plan: May 2021

Enabling act:

Pest Control Products Act

Description:

We are proposing regulatory amendments to the Pest Control Products Regulations to:

• exempt certain classes of pest control devices and products from the registration requirements under the Pest Control Products Act
  • for example, to eliminate regulatory duplication, provide access to certain low risk products, codify current policies and ensure appropriate oversight of regulated products
• clarify the scope of the requirements for devices to ensure there are no regulatory gaps, while allowing some low-risk devices, such as mousetraps, to be authorized without extra conditions

We identified this regulatory initiative in the Agri-food and Aquaculture Sector Regulatory Review Roadmap and Health Canada's Regulatory Stock Review Plan.

We also identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The proposed regulatory amendments would help businesses better determine if their products or devices must be registered and if they reflect current marketplace needs. It would also strengthen health and environmental protection by eliminating possible regulatory gaps.

We expect that the administrative burden would be reduced.

Consultations:

We held pre-consultations with stakeholders in advance of Canada Gazette, Part I, starting on November 30, 2018. This consultation period lasted 90 days.

Additional pre-consultations took place from March 7 to June 5, 2025, including information webinars on May 20 and 21, 2025. This consultation period lasted 90 days.

People in Canada will have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in spring 2026 and last 70 days.

We plan to publish the amended regulations in the Canada Gazette, Part II in winter/spring 2027.

For more information, contact:

Jordan Hancey
Director
Policy and Regulatory Affairs Division
Pest Management Regulatory Agency
613-302-3886
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Date when first included in the plan: May 2019

Enabling act:

Pest Control Products Act

Description:

We are proposing to amend the Pest Control Products Regulations to make the information that is presented in labels more consistent and readable. The amendments would permit the use of electronic labels and internationally aligned globally harmonized system (GHS) standards. Amendments to renewals would also be made 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.

We identified this regulatory initiative in the Agri-food and Aquaculture Sector Regulatory Review Roadmap. It is also associated with Health Canada's Regulatory Stock Review Plan.

We also identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

The option to use GHS labels would align Canada with other international markets, while also staying in line with the United States.

Potential impacts:

The proposed regulatory amendments would make labels more readable. This would help users understand and find the information they need to help them use pest control products safely and effectively.

Electronic labels and international formats (for example, the GHS for classifying and labelling chemicals) may reduce costs for regulated parties. Electronic labels will also allow users to access the most up-to-date label information, enhancing health and environmental protection.

The proposed changes to renewals should reduce administrative burden. Not having to submit renewal applications and pay application fees would also save time and cost for most companies.

Consultations:

People in Canada will have the opportunity to comment on the regulatory proposal during a pre-consultation in spring 2026 and during the Canada Gazette, Part I public comment period. This is expected to take place in winter 2027 and last 75 days.

We plan to publish the amended regulations in the Canada Gazette, Part II in fall 2027.

For more information, contact:

Jordan Hancey
Director
Policy and Regulatory Affairs Division
Pest Management Regulatory Agency
613-302-3886
Email: jordan.hancey@hc-sc.gc.ca

Date when first included in the plan: May 2019

Enabling act:

Pest Control Products Act

Description:

We are proposing to amend the Pest Control Products Regulations to extend the current exemption from the application of the Pest Control Products Act of antimicrobial- treated Class II, III and IV medical devices to also include antimicrobial-treated Class I medical devices (as defined under the Medical Devices Regulations).

We identified this regulatory initiative in the Health Canada and the Public Health Agency of Canada’s report on red tape review.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

We expect that the proposed amendments will reduce regulatory and administrative burden, while maintaining health and environmental protection. The proposed amendments would also eliminate potential regulatory overlap with the Food and Drugs Act.

Consultations:

People in Canada had the opportunity to comment on the regulatory proposal during a 30-day public comment period, from June 2 to July 2, 2025. An information webinar also took place on June 13, 2025.

We plan to publish the amended regulations in the Canada Gazette, Part II in fall 2025.

For more information, contact:

Jordan Hancey
Director
Policy and Regulatory Affairs Division
Pest Management Regulatory Agency
613-302-3886
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Date when first included in the plan: December 2025

Enabling act:

Tobacco and Vaping Products Act

Description:

We are proposing to repeal the Tobacco Access Regulations and propose a new regulation, the Tobacco and Vaping Access Regulations, to support measures in the Tobacco and Vaping Products Act that protect the health of young people. The measures restrict access to tobacco and vaping products.

The proposed regulations would set out in greater detail the actions that regulated parties involved in online or distance sales may take to verify age and identity.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The proposed regulatory amendments would impact anyone who engages in online sales of tobacco and vaping products. They would detail measures that retailers, senders and deliverers can implement to show that they attempted to prevent sales to youth.

These amendments would also make it harder for youth to access tobacco and vaping products.

Consultations:

We published a consultation document on April 11, 2019. This document sets out potential regulatory measures to reduce youth access and minimize the appeal of vaping products.

For a summary of the consultation, visit:

• What we heard: Reducing youth access and appeal of vaping products: Consultation summary

People in Canada will have an opportunity to comment on the regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in spring 2025 and last 60 days.

Learn more:

• About vaping

For more information, contact:

Cecilia Van Egmond
Director
Office of Compliance and Regulatory Affairs
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
613-790-9957
Email: pregs@hc-sc.gc.ca

Date when first included in the plan: February 2021

Enabling act:

Tobacco and Vaping Products Act

Description:

We are amending the Tobacco and Vaping Products Act and introducing new regulations to establish new restrictions for vaping products. Our goal is to lower the appeal of vaping products as a way to protect young people.

The amending order and the regulations will:

• restrict the promotion of flavours in vaping products to tobacco or mint or menthol, including through indications or illustrations on packaging
• prohibit the use of all sugars and sweeteners as well as most flavouring ingredients, with limited exceptions for tobacco and mint/menthol flavours
• prescribe standards for sensory attributes, to prevent a sensory perception other than one that is typical for tobacco or mint/menthol

Reducing the promotion and appeal of vaping products to young people are commitments made in the Minister of Health's 2019 Mandate Letter.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The order and regulations will impact vaping product manufacturers, importers and retailers. They will be required to manufacture and sell only those vaping products that comply with the requirements.

Consultations:

We published a consultation document on April 11, 2019, setting out potential regulatory measures to reduce youth access and appeal of vaping products.

For a summary of the consultation, visit:

• What we heard: Reducing youth access and appeal of vaping products: Consultation summary

We pre-published the proposed changes in the Canada Gazette, Part I on June 19, 2021, followed by a 75-day public comment period.

Timing for publication in Canada Gazette, Part II is to be determined.

Learn more:

• About vaping

For more information, contact:

Cecilia Van Egmond
Director
Office of Compliance and Regulatory Affairs
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
613-790-9957
Email: pregs@hc-sc.gc.ca

Date when first included in the plan: February 2021

Enabling act:

Tobacco and Vaping Products Act

Description:

We are proposing to:

• consolidate the Tobacco Reporting Regulations and Vaping Products Reporting Regulations into 1 set of regulations
• modernize the information that we collect from manufacturers and importers of tobacco and vaping products

The Minister would also be required to disclose certain information to the public.

Regulatory cooperation efforts (domestic and international):

This initiative is not part of a formal regulatory cooperation work plan.

Potential impacts:

The proposed regulatory amendments would:

• improve the information that we collect from manufacturers and importers of tobacco products and vaping products
• help us make decisions and policies aimed at continuing to reduce tobacco use in Canada

The disclosure requirements would give people in Canada better access to the tobacco product and vaping product information that we collect.

Manufacturers would be required to make changes to the tobacco product and vaping product information that they submit in their reports.

Consultations:

We published a notice of intent in the Canada Gazette, Part I on March 2, 2024, followed by a 60-day public comment period.

People in Canada will have an opportunity to comment on the regulatory proposal during the Canada Gazette, Part I public comment period. This is expected to take place in fall 2026 and last 75 days.

Learn more:

• Tobacco Reporting Regulations
• Vaping Products Reporting Regulations

For more information, contact:

Cecilia Van Egmond
Director
Office of Compliance and Regulatory Affairs
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
613-790-9957
Email: pregs@hc-sc.gc.ca

Date when first included in the plan: April 2017