Forward Regulatory Plan: 2024-2026

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

Biocides Regulations

Enabling act:

Description:

We plan to amend the Food and Drug Regulations, Natural Health Products Regulations and Pest Control Products Regulations. The amendments will ensure a consistent and flexible approach to the regulation of biocides (surface disinfectants and surface sanitizers).

Currently, biocides are regulated under separate regimes, which creates challenges for industry and regulators. This was very evident during the COVID-19 pandemic.

The proposed amendments will:

create 1 comprehensive framework for regulating biocides
enable regulatory oversight based on risk and evolving evidence
introduce a use of foreign decisions pathway

Note: The Biocides Regulations were previously named Regulations Amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and surface sanitizers).

This initiative is a part of broader work on modern regulations related to the Health and Biosciences Sector Regulatory Review Roadmap.

Regulatory cooperation efforts (domestic and international):

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

The revised regulations will allow the use of regulatory decisions from trusted foreign regulators such as the U.S. Environmental Protection Agency (EPA) for these products.

Potential impacts:

The regulations will apply to businesses involved in selling biocide products in Canada.

We expect these regulations will reduce barriers and create efficiencies for most businesses wanting to bring biocides to the Canadian market. This will result in timely access to biocides for people in Canada. Benefits may vary between companies.

Consultations:

We met with industry associations in July 2019, April 2021, January 2022 and May 2022 to discuss key components of the framework.

We worked closely with industry stakeholders throughout the COVID-19 pandemic to help make biocides more available to people in Canada. Lessons learned from the pandemic informed the proposed Biocides Regulations.

We pre-published the regulatory proposal in the Canada Gazette, Part I on May 7, 2022, followed by a 70-day public comment period. A consultation on an associated fee proposal took place at the same time.

We held additional meetings and sessions with industry associations in December 2022, March 2023 and June 2023.

We will consider the feedback received from stakeholder consultations and pre-publication when we publish the regulations in the Canada Gazette, Part II. This is expected to take place in spring 2024.

For more information, contact:

Date when first included in the plan: February 2021

Precision Regulating

Enabling act:

Description:

We are exploring tools that would help to address market gaps and vulnerabilities for health products and food, and mitigate risks from unauthorized use of certain health products.

These tools would:

put in place targeted exemptions from specific requirements in the Food and Drugs Act and its associated regulations, with conditions where appropriate, while continuing to ensure that health and safety standards are met
rely on information or decisions from trusted international regulatory authorities to satisfy specific requirements in the Food and Drugs Act and its associated regulations
put in place supplementary rules for certain health products that have the potential to cause harm through unauthorized use

These tools would help to respond to supply disruptions, address gaps in the products available in Canada, and take action when there is a potential risk to health, safety or the environment. They would be carefully crafted to respect the health and safety requirements of the Food and Drugs Act and its associated regulations. Our goal is to ensure that people in Canada have access to the health products and food they need.

We identified an aspect of this regulatory initiative in the Agri-food and Aquaculture Sector Regulatory Review Roadmap.

This regulatory initiative is 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 proposal would prioritize safety and facilitate access to important health products or foods that are not readily available in Canada.

Consultations:

We are planning further policy consultations in spring 2024.

For more information, contact:

Date when first included in the plan: April 2018

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 in 2024.

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 Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)

Enabling act:

Description:

We are proposing to amend the Food and Drug Regulations and Medical Devices Regulations to implement an agile, modern licensing scheme for drugs (prescription and over-the-counter) and medical devices in Canada. These amendments will enhance safety and ensure appropriate oversight while also supporting innovation.

The amendments will:

implement agile regulations that support timely access to innovative drugs and medical devices
enable regulatory oversight based on risk and evolving evidence
harmonize and align internationally
improve transparency about the risks, benefits and uncertainties of drugs and medical devices

We identified this regulatory initiative in 2 roadmaps:

This regulatory initiative is 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.

The amendments will better align Canada's requirements with those of other jurisdictions, such as the US and European Union.

Potential impacts:

The amendments apply to health and biosciences industries (human and veterinary) conducting business in Canada.

The amendments will:

improve the risk-based regulation of drugs and medical devices, both before and after they are on the market
increase support for better decision-making by patients, health care practitioners and provinces and territories
encourage businesses to bring innovative, safe, high-quality drugs to the Canadian market in the case of a public health emergency

Consultations:

We consulted stakeholders on aspects of this initiative in 2020 and 2021, specifically on the interim orders related to COVID-19. Certain parts of the associated transition regulations have similar regulatory approaches to those in this proposal.

We published a notice of intent in July 2021 proposing targeted amendments to the Food and Drug Regulations and Medical Devices Regulations.

We pre-published the proposed changes in the Canada Gazette, Part I on December 17, 2022, followed by a 130-day public comment period.

We plan to publish the amended regulations in the Canada Gazette, Part II in fall 2024.

Learn more:

For more information, contact:

Date when first included in the plan: June 2019

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.

Interested parties 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 2024.

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:

evaluation of applications of natural health products
review of site licences
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 industry compliance with regulatory requirements. This would 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 our website 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 2023 and July 2023 to discuss the fee proposal.

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 would apply to health and biosciences and agri-food 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.

The benefits include:

improved safety monitoring for Canadian participants in trials
ability to apply for investigational testing of medical devices (without going through a manufacturer) for health care providers
ability to conduct clinical trials for infant formula and other prescribed foods for a special dietary purpose within Canada for agri-food businesses

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

Regulations Amending the Food and Drug Regulations (Modernize Food Regulations to Enable Innovative and Safe Foods for People in Canada)

Enabling act:

Description:

We are proposing to amend the Food and Drug Regulations to modernize the regulation of food. The intent is to encourage businesses to bring safe and innovative products to market in Canada.

The proposed amendments will:

create a regulatory framework to enable continued use of human milk fortifiers
- completed
modernize the regulatory frameworks for microbiological safety criteria and methods of analysis, to help us respond to advances in science and technology
streamline food additive rules
establish a new regulatory framework for foods supplemented to contain added ingredients like vitamins or caffeine, to safely allow them on the Canadian market
- completed

These priority areas are the first steps to implementing a modernized and redesigned framework for food regulations under the Act.

We identified this regulatory initiative in the Agri-food and Aquaculture Sector Regulatory Review Roadmap. This regulatory initiative is associated with Health Canada's Regulatory Stock Review Plan. It is also linked to the Health Canada and Canadian Food Inspection Agency joint policy statement on food labelling coordination.

Regulatory cooperation efforts (domestic and international):

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

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

Potential impacts:

The proposed amendments will apply to businesses that sell regulated food products in Canada.

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

Consultations:

We consulted stakeholders on the initiative in October 2022. Through webinars, we gave food industry stakeholders an overview of the different areas of the Food and Drug Regulations that we are modernizing. We talked about the purpose of our modernization work and what we intend to accomplish.

We pre-published the proposed changes for microbiological criteria for foods, scientific methods of analysis and food additives in the Canada Gazette, Part I on November 4, 2023, followed by a 90-day public comment period. We plan to publish the amended regulations in the Canada Gazette, Part II in fall 2024.

We published the changes for supplemented foods in the Canada Gazette, Part II on July 20, 2022 as stated in the joint statement on food labelling coordination, the compliance date for the supplemented food amendments is January 1, 2026. We published changes for human milk fortifiers in the Canada Gazette, Part II on April 14, 2021

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 proposed 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, 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 would align Canadian requirements for medical device recalls with the United States. This would help to harmonize the regulations for medical devices under the Canada-U.S. Regulatory Cooperation Council.

The amendments would also address a recommendation from Canada's Economic Strategy Tables to adopt requirements that align with international best practices. This would 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.

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

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 are considering all comments when preparing the proposal for final publication.

We plan to publish the amended regulations in the Canada Gazette, Part II in spring 2024.

Phase 2:

People in Canada will 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 winter/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 will:

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 will happen 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 will better align Canada's regulations with those of the U.S., European Union, United Kingdom, Australia and Switzerland.

The amendments for drug recalls will 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 will allow importers and distributors to rely on the results from release testing conducted by the foreign fabricator. They will be 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 will support clear and accurate regulations for DEL holders.

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

Potential impacts:

Phase 1 amendments will 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 will 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 are considering these comments in preparing the proposal for final publication.

We plan to publish the amended regulations in the Canada Gazette, Part II in spring 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, and 2023, 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.

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 the fee proposal in 2024.

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

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

Regulatory Amendments to Address Therapeutic Product Shortages in Canada

Enabling act:

Description:

We are proposing to amend the Food and Drug Regulations and the Medical Devices Regulations to help make the supply chain more resilient and better prevent and mitigate shortages.

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

establish and maintain practices and procedures to help identify, analyze and address drugs that are at risk of going into shortage
take specific action, for example, by requiring safety stocks of critical drugs that are vulnerable to shortages

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 therapeutic products
provide new regulatory agility to help mitigate shortages, for example, by extending expiration dates for drugs in certain cases

These proposed amendments would help us:

better prevent and mitigate 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 therapeutic product 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:

improve the resiliency of the supply chain for critical drugs vulnerable to shortages in Canada
help prevent health product shortages before they affect patients
provide the department with better tools to mitigate health product shortages

There may be an increased burden on industry, as businesses would need to assess their own shortage risks and work to address them. However, we expect that companies would also experience greater efficiencies.

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 2024 and last 70-days.

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

We held public consultations to identify challenges and solutions to improve access to drugs and other health products in Canada from June to August 2023. 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

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.

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 2024 and last 60-days.

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.

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 spring 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: 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 fall 2024.

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:

Radiation Emitting Devices 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 winter 2025 and during the Canada Gazette, Part I public comment period. This is expected to take place in fall 2026 and last 75-days.

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: jordan.hancey@hc-sc.gc.ca

Date when first included in the plan: May 2019

Radiation Emitting Devices Act

Regulations Amending the Radiation Emitting Devices Regulations (Laser Products)

Enabling act:

Description:

We are proposing to amend the Radiation Emitting Devices Regulations to:

better protect people in Canada from laser radiation hazards
align Canadian requirements with international standards
address a broader range of laser devices

The proposed amendments would align Canada's regulations with the International Electrotechnical Commission's standard. The IEC 60825-1, Safety of laser products - Part 1: Equipment classification and requirements, Ed. 3.0, 2014 standard is used or referenced by Canada's key trading partners.

The amended regulations would require appropriate laser warning labels and establish minimum design safety features for specific laser classes and hazard levels. This would make laser products that are imported, sold, leased and advertised in Canada safer.

The proposed amendments would also address laser devices beyond laser scanners and demonstration lasers.

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.

The IEC 60825-1 standard is a new international standard for laser products since the laser regulations were last amended. Canada's major trading partners are in the process of harmonizing (U.S.) or have already harmonized (Australia, European Union, United Kingdom, Japan, South Korea) their standards with this international standard.

Adopting the IEC 60825-1 standard would align Canada with the regulatory standard used internationally.

Potential impacts:

The proposed amendments to require warning labels on how to mitigate laser hazards would better protect people from accidental or inadvertent exposure to laser emissions. Manufacturers would also be required to integrate safety controls and features in their laser devices.

We expect that the impacts on industry would be minimal due to efforts to align with the international standard and reduce regulatory burden.

Consultations:

We conducted an online public consultation process on June 30, 2021. The 60-day consultation period ended on August 30, 2021.

We pre-published the proposed changes in the Canada Gazette, Part I on July 1, 2023, followed by a 75-day public comment period.

We plan to publish the amended regulations in the Canada Gazette, Part II in fall 2024.

For more information, contact:

Tara Bower
Director
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
613-957-6371
Email: erhsdgeneral-dssergenerale@hc-sc.gc.ca

Date when first included in the plan: February 2021

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

Learn more:

About vaping

For more information, contact:

Denis Choinière
Director
Tobacco Products Regulatory Office
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
613-859-5669
Email: pregs@hc-sc.gc.ca

Date when first included in the plan: February 2021

Order Amending Schedules 2 and 3 to the Tobacco and Vaping Products Act (Flavours) and Standards for Vaping Products' Sensory Attributes Regulation

Enabling act:

Description:

We are amending the Tobacco and Vaping Products Act (flavours) to include a new standard 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 flavouring ingredients, with limited exceptions (tobacco and mint or 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.

We plan to publish the amending order and the regulations in the Canada Gazette, Part II in spring 2024.

Learn more:

About vaping

For more information, contact:

Denis Choinière
Director
Tobacco Products Regulatory Office
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
613-859-5669
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.

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 winter 2025 and last 75-days.

Learn more:

For more information, contact:

Denis Choinière
Director
Tobacco Products Regulatory Office
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
613-859-5669
Email: pregs@hc-sc.gc.ca

Date when first included in the plan: April 2017

Regulations Amending the Tobacco Products Appearance, Packaging and Labelling Regulations

Enabling act:

Description:

We are proposing to amend the Tobacco Products Appearance, Packaging and Labelling Regulations. Minor technical amendments would clarify requirements for the placement of health-related messages on certain types of tobacco product packages, specifically on a secondary package that is a carton.

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 public more aware of the health hazards of using tobacco products
prevent the public from being deceived or misled about these hazards

Placing health-related messages on the packaging of tobacco products is recognized as one of the best approaches to inform people of the health hazards of tobacco use.

Manufacturers may need to make changes to where they display health-related messages on the packages of their tobacco products.

Consultations:

The Tobacco Products Appearance, Packaging and Labelling Regulations were published in the Canada Gazette, Part II, in June 2023.

We held a targeted consultation on labelling issues raised by regulated parties in fall 2023.

We plan to publish the amended regulations in the Canada Gazette, Part II in spring 2024.

Learn more:

Tobacco Product Labelling

For more information, contact:

Denis Choinière
Director
Tobacco Products Regulatory Office
Tobacco Control Directorate
Controlled Substances and Cannabis Branch
613-859-5669
Email: pregs@hc-sc.gc.ca

Date when first included in the plan: May 2024

Tobacco Cost Recovery Regulations

Enabling act: