Health Canada’s Forward Regulatory Plan: 2024-2026

Controlled Drugs and Substances Act

Description:

We are proposing to amend the Cannabis Regulations, Cannabis Tracking System Order, Industrial Hemp Regulations, Cannabis Exemption (Food and Drugs Act) Regulations, Natural Health Products Regulations and Schedule 2 to the Cannabis Act while maintaining the public health and public safety objectives of the Cannabis Act. The amendments would:

reduce regulatory and administrative burden on industry by eliminating inefficiencies
respond to feedback received from stakeholders, including industry
allow for increased innovation for the cannabis industry

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 and administrative burden on regulated parties, while continuing to support the public health and public safety objectives of the Cannabis Act.

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

Consultations:

We sought public feedback on potential regulatory changes through a notice of intent in the Canada Gazette, Part I, on December 12, 2020, followed by a 30-day public comment period.

We also sought comments on potential changes to the Cannabis Regulations by publishing a notice of intent in the Canada Gazette, Part I, on March 25, 2023, followed by a 60-day public comment period.

We pre-published proposed changes in the Canada Gazette, Part I on June 8, 2024, followed by a 30-day public comment period. We will review and consider the comments received, which will help us prioritize final regulatory amendments that we plan to publish in the Canada Gazette, Part II in spring 2025.

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: April 2022

Controlled Drugs and Substances Act

Modernization of Regulations for Controlled Substances

Enabling 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:

This consolidation would modernize the regulatory language used throughout the proposed new regulation.

We also intend 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 planned consolidation, we would propose 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.

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 be clearer, more consistent and 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 first signalled our intent to modernize the provisions in our Forward Regulatory Plan:

in 2016 for provisions related to individuals, destruction and test kits
in 2019 for provisions related to pharmacists

We sought feedback on the proposed regulatory changes as follows:

for returning, destroying and travelling with controlled substances through a notice to interested parties
- published in the Canada Gazette, Part I on October 28, 2017, followed by a 60-day public comment period
for test kits through a notice to interested parties
- published in the Canada Gazette, Part I on March 31, 2018, followed by a 60-day public comment period
for pharmacists through a notice to interested parties
- published in the Canada Gazette, Part I on March 9, 2019, followed by a 60-day public comment period

We pre-published the consolidated and modernized regulatory provisions 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 will consider 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 spring 2025.

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

Food and Drugs Act

Regulatory modernization of foods for special dietary use and infant foods: Divisions 24 and 25 of the Food and Drug Regulations

Enabling act:

Description:

We are proposing to take a comprehensive approach to modernizing Divisions 24 and 25 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:

support increased innovation
improve alignment with international jurisdictions
reduce barriers to importing these foods into Canada

The new regulatory framework would:

improve access to these critical nutrition products for people in Canada
promote a diverse market to reduce the risk of shortages

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 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.

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 2026.

Learn more:

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

Regulations Amending the Natural Health Products Regulations and the Food and Drug Regulations (Self-Care Framework)

Enabling act:

Description:

We are proposing to amend the Natural Health Products Regulations and Food and Drug Regulations to align the risk-based approach to the regulatory oversight of self-care products. As the scope of these amendments is significant, we will be developing separate regulatory proposals.

Proposed amendments to the Food and Drug Regulations include expedited pathways, such as a class-based licensing system, for lower-risk non-prescription drug products. The amendments would align the requirements for these products with natural health products that have similar characteristics and uses.

The proposed amendments would also modernize the Natural Health Products Regulations by creating a risk-based categorization structure and enhanced quality oversight. Amendments concerning natural health products include those that would:

introduce an annual notification to identify marketed products
strengthen the requirements for good manufacturing practices
introduce a risk-based site licensing program

These proposed amendments address the recommendations for natural health products made by the Commissioner of the Environment and Sustainable Development in the 2021 audit.

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.

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., European Union and Australia.

Potential impacts:

The proposed amendments would apply to businesses involved in selling natural health products and non-prescription drugs in Canada. Proposed amendments to the:

Natural Health Products Regulations would strengthen oversight and assure people in Canada of the quality of marketed natural health products
Food and Drug Regulations would maintain adequate regulatory oversight of high quality products while reducing regulatory burden and introducing greater efficiencies to businesses

Consultations:

We have consulted with stakeholders since 2016 and will continue to do so.

We published the regulatory amendments to improve the labelling of natural health products in the Canada Gazette, Part II on July 6, 2022.

Learn more:

For more information, contact:

Date when first included in the plan: April 2015

Regulations Amending the Food and Drug Regulations (Advertising to Children of Certain Foods Containing Sugars, Sodium or Saturated Fat)

Enabling act:

Description:

We are proposing to amend the Food and Drug Regulations to prohibit the advertising to children of certain foods containing sugars, sodium or saturated fat.

Our intent is to help reduce children's overconsumption of these nutrients of concern, as these are associated with an increased risk of developing diet-related chronic disease.

Restricting the commercial marketing of food and beverages to children was identified as a commitment in the Minister of Health's 2021 Mandate Letter.

Regulatory cooperation efforts (domestic and international):

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

Potential impacts:

This proposal would reduce children's exposure to influential advertising of certain foods containing sugars, sodium or saturated fat. This would lead to healthier eating habits and, thus, lower the risk of diet-related chronic diseases and their associated risk factors now and later in life. Businesses involved in advertising food to children may see reduced revenues.

The proposed prohibitions would apply to companies and other parties that advertise food to children, including:

food manufacturers
producers and importers
food retailers and restaurants
advertising and marketing agencies

Consultations:

We consulted extensively on this initiative between 2016 and 2019. We also consulted on an updated policy approach in spring 2023 (online and through webinars). We included industry, health stakeholders and members of the public in the consultations.

Learn more:

For more information, contact:

Date when first included in the plan: April 2021

Amendments to the Fees in Respect of Drugs and Medical Devices Order (Natural Health Products Fee Proposal)

Enabling act:

Description:

We are proposing to amend the Fees in Respect of Drugs and Medical Devices Order (fees order). The amendments would expand the existing fees order to include the:

review of applications for NHP licences
amendments to NHP product licences
review of applications for NHP site licences
amendments to NHP site licences and
right to sell natural health products in Canada

The proposed amendments are in response to the recommendations and findings in the audit report by the Commissioner of the Environment and Sustainable Development.

We need to recover costs to make improvements to the natural health products program, in response to the audit.

Cost recovery would help offset the costs of some program services to industry, which are currently fully funded by taxpayers. Also, the revenue generated by the proposed fees would help us:

create an even safer marketplace for consumers
help industry comply with regulations through education and guidance
conduct inspections to ensure that natural health products are manufactured, imported, labelled and packaged in accordance with the regulations

Regulatory cooperation efforts (domestic and international):

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

Potential impacts:

The natural health product industry employs more than 50,000 people and generates billions in domestic sales and exports.

We are considering a number of measures to help alleviate the impact of the proposed fees on businesses. These measures include fee reductions for small businesses and an exemption from the pre-market evaluation fee for small businesses marketing their first product.

With the revenue from the proposed fees, we would establish a new, permanent good manufacturing practices inspection program. Through this program, we will educate industry on its obligations and verify that industry is complying with the regulatory requirements.

This new inspection program will help ensure that people in Canada have continued access to a safer marketplace for these products.

Consultations:

We held an initial stakeholder information session in February 2022.

We also published a fee proposal for consultation on May 12, 2023, followed by a notice of intent in Canada Gazette, Part I on May 13, 2023. This 90-day consultation closed on August 10, 2023.

We held technical briefings with stakeholders in May and July 2023 to discuss the fee proposal.

Since the end of the consultation period, we held a targeted session with industry associations on March 27, 2024. At the same time, we posted a public notice on the updated policy for 60 days.

We are reviewing the comments and will determine what changes to make to the proposal to mitigate impacts on small businesses. We will engage stakeholders further, as necessary.

Learn more:

For more information, contact:

Date when first included in the plan: April 2022

Clinical Trials Modernization - Drugs

Enabling act:

Description:

We are proposing to amend the Food and Drug Regulations, Natural Health Products Regulations and Medical Devices Regulations to modernize the regulation of clinical trials conducted in Canada.

The proposed amendments 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
streamline regulatory processes to make them more efficient and clear
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 amendments that relate to drugs.

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.

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 amendments for the first phase would apply to health and biosciences stakeholders involved in the conduct of 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 those who participate 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 spring 2025.

Learn more:

For more information, contact:

Date when first included in the plan: June 2019

Modernizing the Medical Device Establishment Licensing (MDEL) Framework

Enabling act:

Description:

We plan to modernize the medical device establishment licensing (MDEL) framework in two phases.

Phase 1: The amendments to the Medical Devices Regulations will improve and modernize the regulatory oversight of medical devices in Canada. To achieve this, we will:

modernize the MDEL application requirements to reflect current practices
give the Minister the ability to issue terms and conditions on an MDEL to mitigate risks to health and safety and strategically target non-compliance
establish a regulatory framework for recalls of medical devices ordered by the Minister, update the recall definition and clarify industry-reporting obligations

Phase 2: The proposed amendments to the Medical Devices Regulations would:

improve and modernize the regulatory oversight of the medical devices supply chain in Canada
address uncertainties around importation introduced into the regulations by a previous regulatory amendment

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.

Note: For regulatory consistency, the Phase 1 amendments to the Medical Devices Regulations will happen at the same time as the Phase 1 amendments to the Food and Drug Regulations. These amendments are part of the Modernizing the Drug Establishment Licensing (DEL) Framework initiative.

Regulatory cooperation efforts (domestic and international):

The Phase 1 amendments will align Canadian requirements for medical device recalls with the United States. This will help to harmonize the regulations for medical devices under the Canada-U.S. Regulatory Cooperation Council.

The amendments will also address a recommendation from Canada's Economic Strategy Tables to adopt requirements that align with international best practices. This will increase international harmonization while protecting the health and safety of people in Canada.

Potential impacts:

Phase 1:

The amended framework will:

create a level playing field with other jurisdictions (such as the U.S., European Union, Switzerland and United Kingdom) for Canada's medical device sector
improve the predictability and efficiency of recalls for industry
decrease the burden on industry when reporting low-risk issues for medical devices

The amendments will benefit the health of people in Canada who use or may use medical devices. They are not expected to disadvantage individuals based on gender, race, culture or other personal or group characteristics.

Phase 2:

The amended framework would improve regulatory oversight of facilities that import and distribute safe medical devices.

Consultations:

We consulted industry and other stakeholders in 2016. We also consulted holders of drug and medical device establishment licences between April and June 2019.

Policy consultations and stakeholder engagement on the Phase 1 measures took place in fall 2021-winter 2022.

We published a notice of intent in the Canada Gazette, Part I on December 11, 2021, followed by a 60-day comment period. This notice informed stakeholders of the policy direction and provided opportunities to comment on the policy approach.

Phase 1:

We pre-published the proposed Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) in the Canada Gazette, Part I on April 15, 2023, followed by a 75-day public comment period.

For the Medical Devices Regulations, stakeholders generally supported the proposed amendments. There were some concerns about the:

24-hour recall reporting requirement
potential health and safety risks of misclassifying or under-reporting recalls
requirement that applicants provide previous names in the MDEL application

We considered all comments when preparing the proposal for final publication.

We published the amended regulations in the Canada Gazette, Part II on July 3, 2024. The amendments to the Medical Devices Regulations came into force on December 14, 2024.

Phase 2:

A notice of intent was published in Canada Gazette, Part I in fall 2024. This notice will inform stakeholders of the proposed policy direction and provide an opportunity to comment on the policy approach. Overall, the proposal was well received with no major objections put forward. Many stakeholders supported efforts to reduce administrative burden by way of reducing redundancies in the MDEL framework.

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 spring 2025 and last 75 days.

Learn more:

Guidance on medical device establishment licensing (GUI-0016)

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

Modernizing the Drug Establishment Licensing (DEL) Framework

Enabling act:

Description:

We plan to modernize the drug establishment licensing (DEL) framework in 2 phases.

Phase 1:

The amendments to the Food and Drug Regulations:

establish a regulatory framework for recalls of drugs ordered by the Minister
clarify reporting obligations for industry for voluntary recalls that are consistent with the current policy
address outdated references in the DEL framework to other regulatory authorities that participate in mutual recognition agreements (MRAs) with Canada
- replace these references with a list incorporated by reference on an ambulatory basis within the regulations and housed on the Government of Canada website
offer conditional exemptions from the requirements for aspects of finished product testing for certain biologics (such as gene and cell therapies) and radiopharmaceuticals where alternative risk mitigation measures and safety controls have been implemented
clarify that direct shipment to a person other than an importer (a health care practitioner or healthcare facility where the drug will be administered) is permitted for certain biologics and radiopharmaceuticals

Phase 2:

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

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.

Note: For regulatory consistency, Phase 1 amendments to the Food and Drug Regulations happened at the same time as Phase 1 amendments to the Medical Devices Regulations. This is part of the Modernizing the Medical Device Establishment Licensing (MDEL) Framework initiative.

Regulatory cooperation efforts (domestic and international):

Phase 1 amendments related to the Food and Drug Regulations better align Canada's regulations with those of the U.S., European Union, United Kingdom, Australia and Switzerland.

The amendments for drug recalls support Canada's international responsibilities by clarifying the reporting obligations for industry, specifically the timelines for complying with the regulations.

The amendments for finished product testing allow importers and distributors to rely on the results from release testing conducted by the foreign fabricator. They are more closely aligned with advanced therapeutic product frameworks in the U.S. and European Union.

The collaborative work between Canada and our international partners through MRAs is a key driver for these amendments. Modernizing the table of designated regulatory authorities support clear and accurate regulations for DEL holders.

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

Potential impacts:

Phase 1 amendments strengthen our oversight over drug recalls and contribute to the safety and quality of Canada's drug supply. Clearly outlining the jurisdictions for which Canada has an MRA and providing conditional exemptions around finished product testing help industry provide expanded access to certain drugs.

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 consulted DEL and MDEL holders between April and June 2019.

On December 11, 2021, we published a notice of intent in the Canada Gazette, Part I, followed by a 60-day comment period.

Phase 1:

We pre-published the proposed changes to the Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) in the Canada Gazette, Part I on April 15, 2023, followed by a 75-day public comment period.

We received comments from 46 respondents during the comment period, including individuals, businesses and associations. Overall, stakeholders supported the proposed amendments, which included changes to the Food and Drug Regulations and Medical Devices Regulations.

For the Food and Drug Regulations, stakeholders generally supported the amendments. There were some concerns about the:

24-hour recall reporting requirement for drugs
conditional exemptions from aspects of finished product testing

We considered these comments in preparing the proposal for final publication.

We published the amended regulations in the Canada Gazette, Part II on July 3, 2024. The amendments concerning designated regulatory authorities and finished product testing in the Food and Drug Regulations came into force on June 17, 2024, on the day the regulations were registered. The remaining amendments for the regulations concerning recalls came into force on December 14, 2024.

We plan to pre-publish the proposed amendments to the Food and Drug Regulations for Phase 2 in the Canada Gazette, Part I in winter/spring 2025, followed by a 75-day comment period.

Learn more:

Guidance on drug establishment licences (GUI-0002)

For more information, contact:

Date when first included in the plan: February 2021

Amendments to the Food and Drug Regulations - Outsourced Drug Preparation (formerly Commercial Compounding)

Enabling 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.

This regulatory proposal would support regulatory oversight for drug products prepared by outsourced drug preparation establishments. It would be designed to protect people in Canada from drug products that are made using unsafe, poor quality practices.

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 products for people 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 representatives in 2023.

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 spring 2025 and last 75 days.

Learn more:

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

For more information, contact:

Date when first included in the plan: October 2014

Updates to Fees in Respect of Drugs and Medical Devices

Enabling act:

Description:

We are proposing to amend the Fees in Respect of Drugs and Medical Devices Order to better reflect the costs to deliver the program.

Regulatory cooperation efforts (domestic and international):

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

Potential impacts:

There may be business impacts, as the revised fees will apply to businesses that sell certain health products in Canada.

Consultations:

We plan to consult stakeholders on a fee proposal in 2025, pending a positive outcome of the on going periodic review.

For more information, contact:

Date when first included in the plan: April 2023

Proposed Approach to the Regulation of Health Products Containing Cannabidiol (CBD) that Would Not Require Practitioner Oversight

Enabling act:

Description:

The proposed regulatory amendments will consider the recommendations of the Science Advisory Committee on Health Products Containing Cannabis, as well as our own policy decisions.

The amendments would help people in Canada access safe, effective and high-quality health products containing cannabidiol (CBD) without a prescription.

Regulatory cooperation efforts (domestic and international):

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

Potential impacts:

The proposed amendments would potentially benefit businesses that intend to sell heath products containing CBD in Canada, including health product manufacturers and cannabis producers.

This proposal would also make it easier for people in Canada to access safe, effective and high-quality health products containing CBD without a prescription.

Consultations:

We first consulted stakeholders in 2019.

We then created the Science Advisory Committee for Health Products Containing Cannabis in 2020. This committee published a report on cannabidiol in July 2022.

At the same time, we published a notice to stakeholders, followed by a 70-day comment period, inviting stakeholders to comment. We also asked them to submit additional scientific evidence on the safety and/or efficacy of non-prescription health products containing CBD.

We plan to consult key stakeholders in 2024-2025.

Learn more:

Science Advisory Committee for Health Products Containing Cannabis

For more information, contact:

Date when first included in the plan: April 2019

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Shortages and Discontinuation of Sale of Drugs and Medical Devices)

Enabling act:

Description:

We are proposing to amend the Food and Drug Regulations and the Medical Devices Regulations to better protect people in Canada from the harms caused by health product shortages.

The proposed amendments would require market authorization holders (MAHs) of certain drugs to:

establish, document and maintain plans to reduce and prevent shortages for drugs that are critical and vulnerable to shortage
report surges in demand and hold safety stocks for certain drugs that are critical and vulnerable to shortage

We are also proposing amendments to:

update regulatory frameworks for the exceptional importation of drugs and medical devices
improve reporting of shortages and discontinuations of drugs and medical devices
provide new regulatory agility to help mitigate shortages, for example, extending expiration dates for drugs in certain cases

These proposed amendments would help us:

better prevent and mitigate shortages of drugs and medical devices
address conduct that increase the likelihood of people in Canada being harmed by shortages of drugs and medical devices
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 would 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 would apply to businesses involved in the sale of drugs and medical devices in Canada.

This regulatory proposal would:

help prevent health product shortages before they affect patients
reduce the likelihood that people in Canada are harmed by drug and medical device shortages
improve the resiliency of the supply chain for critical drugs vulnerable to shortages in Canada
provide the department with better tools to mitigate health product shortages

There may be an increased burden on industry, as some businesses would develop plans and procedures or take other measures to prevent shortages of drugs that are critical and vulnerable to shortage. However, we expect that companies would also experience greater efficiencies from improved reporting and exceptional importation frameworks.

Consultations:

People in Canada have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I 70-day public comment period, from December 28, 2024, to March 8, 2025.

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

We also 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

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.

Learn more:

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

Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine

Enabling act:

Description:

We are proposing a ministerial order that would replace the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine. The interim order will expire by May 17, 2025. A ministerial order would ensure that sale-related rules for natural health products containing ephedrine or pseudoephedrine continue to apply to such products to prevent their diversion and misuse.

Regulatory cooperation efforts (domestic and international):

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

This proposal would continue to align Canada's requirements beyond the interim order with those of other jurisdictions, such as the US and the UK. In the US, these products are, at a minimum, sold from behind the counter. In the UK, consumers can only purchase these products from pharmacies and under a pharmacist's supervision.

This proposal would also continue to align requirements for these products across provinces and territories.

Potential impacts:

The proposed ministerial order would apply to businesses that sell certain natural health products containing ephedrine or pseudoephedrine. It would continue to regulate these products at their place-of-sale to prevent their diversion and misuse, to protect the health and safety of people in Canada.

Consultations:

We consulted stakeholders when the interim order was being developed in spring 2024. We consulted stakeholders on the ministerial order in fall 2024.

For more information, contact:

Date when first included in the plan: January 2025

Ministerial Class Exemption Order for the exceptional importation of certain foods for a special dietary purpose to mitigate a shortage or the risk of a shortage

Enabling act:

Description:

We are proposing to make a ministerial class exemption order under the Food and Drugs Act, sub-section 30.05(1), 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 policy has been in place since March 2022 and will expire on December 31, 2025.

Under the order and subject to conditions, licence holders will be able to import and sell certain non-compliant foods for a special dietary purpose when there is a shortage or a risk of a shortage. Such foods include infant formula, human milk fortifier and formulated liquid diets.

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, we will be able to access certain foreign-made foods for a special dietary purpose that may not fully meet Canada's regulatory or labelling 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. Their health will be seriously impacted if they are unable to access these products.

The order would establish a transparent, predictable and legally enforceable framework to maintain access to these foods during 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 shortage 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.

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

For more information, contact:

Date when first included in the plan: January 2025

Pest Control Products Act

Regulations Amending the Pest Control Products Fees and Charges Regulations (Annual Charge)

Enabling acts:

Description:

We are looking at the appropriateness of existing fees and charges, and the potential need to amend the Pest Control Products Fees and Charges Regulations. We last updated our fees for pesticides in 2017 based on 2011 data. The current fees do not reflect the department's post-market regulatory costs to support, for example, scientific re-evaluations of registered pesticides and compliance and enforcement activities. Taxpayers are also assuming an increasing economic burden.

This set of proposed amendments focuses on the annual charge.

In a second phase (anticipated in 2028), we will seek to align our fees to reflect changes made to the pesticide program, in particular those that modernize business processes. This will include:

updating application fees to register new pest control products
amending existing registrations

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 make the pest control product regulatory process more sustainable by recovering from fee payers an increased part of post-market regulatory costs incurred by delivering the program. This is in line with the benefits that fee payers receive.

Consultations:

We held consultations with key stakeholders from January to April 2024. We are reviewing the comments received as we prepare the regulatory proposal for pre-publication.

People in Canada have the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I 60-day public comment period, from December 21, 2024, to February 19, 2025.

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

For more information, contact:

Lars Juergensen
Associate Director
Office of Program Renewal
Pest Management Regulatory Agency
613-818-8542
Email: lars.juergensen@hc-sc.gc.ca

Date when first included in the plan: November 2023

Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada)

Enabling act:

Description:

We are proposing regulatory amendments in response to the spring 2022 consultations on the targeted review of the Pest Control Products Act.

The proposed amendments would:

make it easier to access confidential test data (CTD) for research and re-analysis purposes
increase transparency for maximum residue limit (MRL) applications for imported food products
give the Minister the explicit authority to require submission of information on cumulative effects on the environment
require the Minister to consider cumulative effects on the environment during risk assessments where information and methodology are available
strengthen consideration of species at risk by giving the Minister the explicit authority to require registrants and applicants to submit information on species at risk

A review of this Act was included in the Minister of Health's 2021 Mandate Letter.

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 transparency and better protect the environment, including wildlife, from risks posed by pesticides in Canada.

They would:

provide timelier and improved access to CTD for research and re-analysis purposes
support the development of independent data on pesticides
make the process for setting MRLs for imported food products more transparent
better protect the environment from risks posed by pesticides

Consultations:

We launched a targeted review of the Pest Control Products Act and published a:

discussion document in spring 2022
what we heard report in fall 2022

From the review, we determined that we can achieve the transformation objectives within the current provisions of the act.

We published a notice of intent on June 20, 2023, followed by an informational webinar on July 25, 2023. The notice was open for comments until September 8, 2023. We held another webinar on December 11, 2023.

People in Canada had the opportunity to comment on the regulatory proposal during the Canada Gazette, Part I 70-day public comment period, from June 15 to August 24, 2024.

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

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: November 2023

Regulations Amending the Pest Control Products Regulations (Research)

Enabling 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 regulatory changes, such as adding exemptions for research on microbial agents, would reduce the administrative burden on regulated parties. While others would increase the burden, we expect that the overall burden would be reduced.

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 2025.

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

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 2021

Regulations Amending the Pest Control Products Regulations (Product Exemptions and Pest Control Product Devices)

Enabling 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, 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

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.

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. An additional pre-consultation is planned for winter 2025.

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 and last 70 days.

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

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

Regulations Amending the Pest Control Products Regulations (Labelling Modernization)

Enabling 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 also permit the use of electronic labels and internationally aligned globally harmonized system (GHS) standards.

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.

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.

Consultations:

People in Canada will have the opportunity to comment on the regulatory proposal during a pre-consultation in spring 2025 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

Tobacco and Vaping Products Act

Amendments to the Tobacco Access Regulations (Age Verification for Online or Distance Sales)

Enabling act:

Description:

We are proposing to amend the Tobacco 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 or distance sales of tobacco and vaping products. Parties such as retailers, senders and deliverers would have to comply with the requirements.

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
Tobacco Products Regulatory Office
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

Order Amending the Schedules to the Tobacco and Vaping Products Act (Flavours) and Vaping Products' Sensory Attributes Regulations

Enabling 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 of tobacco or mint or 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
Tobacco Products Regulatory Office
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

Tobacco and Vaping Products Reporting Regulations

Enabling 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.

Learn more:

For more information, contact:

Cecilia Van Egmond
Director
Tobacco Products Regulatory Office
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

Tobacco Cost Recovery Regulations

Enabling act: