Health Canada's Regulatory Stock Review Plan: 2022 - 2024

Enabling act

Food and Drugs Act

Rationale

Stakeholders raised concerns related to the misalignment of Canada’s records retention requirements with those applicable in other jurisdictions. The retention periods were established almost twenty years ago, and reflected industry standards at that time.

Reducing the records retention period decreases the regulatory burden on businesses conducting clinical trials in Canada and contributes to encouraging this sector to conduct more trials in Canada. This could lead to the development of new innovative, generic drugs or natural health products for the Canadian market.

Narrative

Amendments to the Food and Drug Regulations, and the Natural Health Products Regulations reduced the records retention requirement from 25 years to a minimum of 15 years for all clinical trials of drugs and natural health products involving human subjects.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap and was highlighted as an early action item in the 2018 Fall Economic Statement.

The amended regulations better align the records retention requirements in Canada with international standards and requirements prescribed by health regulators in countries such as Australia, France, and Switzerland, which maintain a retention period up to 15 years.

Date of last review or amendment

2001 (last amended)

2018, 2020 (last reviewed)

A full review was conducted in March 2021 to align the records retention requirement of 15 years in the Food and Drug Regulations and the Natural Health Products Regulations. 

Targeted start for review

2021

Stakeholder feedback

Stakeholders from patient safety organizations, academic researchers, medical professional groups, and industry were consulted on the review, and their feedback was taken into consideration in preparing the amendments.

Stakeholders were generally supportive of the amendments. Health Canada published a What We Heard Report: Records Retention Consultations related to the Clinical Trials Interim Order Transition Regulations on January 14, 2022.

Outcomes

The review is complete. 

Subsection C.05.012(4) in the Food and Drug Regulations and subsection 76(4) of the Natural Health Products Regulations were amended in February 2022. The resulting amendments to the Food and Drug Regulations and Natural Health Products Regulations were published in Canada Gazette, Part II on March 2, 2022. 

These amendments reduce the records retention period for all clinical trials of drugs and natural health products involving human participants, from 25 to 15 years, with no exceptions.

The amendments are expected to achieve the following outcomes:

• A reduction in unnecessary regulatory differences; and,
• A reduction in the financial and administrative burden of maintaining records on sponsors and investigators, while the health and safety of Canadians continues to be protected.

The amendments do not affect Health Canada’s internal record-keeping requirements.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Email:  prsd-questionsdspr@hc-sc.gc.ca

Enabling act

Canada Consumer Product Safety Act

Rationale

Health Canada is proposing amendments to the Carriages and Strollers Regulations as the current regulations contain performance requirements and test methods that may not address the hazards related to designs developed after 1985. The current requirements may also unduly limit Canadian consumers’ access to new design features that pose minimal risk.

Narrative

Health Canada is proposing to amend the Carriages and Strollers Regulations to align the terminology with current usage and to provide clearer definitions, which will support innovative product design while enhancing safety for carriages and strollers.

The current requirements also restrict the use of some new design features even if they pose minimal risk, possibly limiting Canadian consumer access to such products.

Review process:

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2022 and last 70 days.

Date of last review or amendment

An internal review of the Regulations was completed in 2015.

No significant updates have been made since the Regulations came into force in 1985.

Targeted start for review

2020

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Enabling act

Canada Consumer Product Safety Act

Rationale

Health Canada is proposing amendments to the Surface Coating Materials Regulations to increase the protection to infants and children from exposure to lead, improve alignment with major trading partners and reduce regulatory burden on industry.

This regulatory proposal would align with the United States requirements for lead in surface coating materials and applied surface coating materials.

Narrative

Health Canada is proposing amendments to the Surface Coating Materials Regulations to increase the protection to infants and children from exposure to lead, improve alignment with major trading partners, and reduce regulatory burden on industry. Health Canada is also proposing consequential amendments to other regulations under the Canada Consumer Product Safety Act to align terminology and requirements for surface coating materials applied to certain consumer products.

Review process:

The amending regulations are expected to be published in the Canada Gazette, Part II in spring-summer 2022.

Date of last review or amendment

An internal review of the regulations was completed in 2016.  

These Regulations were last amended in 2011.

Targeted start for review

2019

Stakeholder feedback

Health Canada pre-published the proposed regulations in the Canada Gazette, Part I on April 24, 2021, with a 70-day public comment period.

Several comments were received from stakeholders who voiced their general support for the proposal. One stakeholder communicated that the changes will align with international requirements and will have a positive economic impact, while still maintaining safety. Several comments included requests to clarify terms used in the Regulations. Some stakeholders communicated their concerns that the proposal did not apply to inaccessible parts and the potential effect of this on human health or the environment. Comments related to testing and alignment with existing voluntary industry standards were also received.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Enabling act

Canada Consumer Product Safety Act

Rationale

Health Canada is proposing amendments to the Tents Regulations to replace the flammability and labelling requirements with the ambulatory incorporation by reference of a new National Standard of Canada developed by the Canadian General Standards Board.

Although modern tents made of synthetic materials are less flammable than traditional cotton canvas tents, they are not fireproof. Proposed amendments to the Tents Regulations would continue to help protect Canadians from injuries and deaths caused by tent fires. The amendments would also introduce flammability requirements for tent trailers.

Narrative

Health Canada is proposing to replace the flammability and labelling requirements under the Tents Regulations through ambulatory incorporation by reference of a new National Standard of Canada developed by the Canadian General Standards Board (CGSB) entitled CAN/CGSB-182.1-2020, Flammability and Labelling Requirements for Tents.

Health Canada is proposing to add these flammability and labelling requirements under the Toys Regulations to ensure CAN/CGSB-182.1-2020 standards also apply to play tents.

Amendments to the Textile Flammability Regulations are also being proposed to continue to exclude flammability requirements for tents and play tents since they are respectively covered by the Tents Regulations and the Toys Regulations.

Review process:

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2023 and last 70 days.

Date of last review or amendment

An internal review of the regulations was completed in 2015.

Targeted start for review

2019

Stakeholder feedback

A notice to interested parties was published on the Government of Canada website on January 22, 2019, with a 60-day public comment period. At that time, Canadians were also invited to provide technical comments on the draft of CAN/CGSB-182.1 to the CGSB.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

• Narcotic Control Regulations;
• Benzodiazepines and Other Targeted Substances Regulations; and,
• Parts G (controlled drugs) and J (restricted drugs) of the Food and Drug Regulations.

Enabling act

Controlled Drugs and Substances Act (CDSA)

Rationale

The Canadian legislative and regulatory framework for controlled substances has evolved to address emerging issues and meet international commitments under the United Nations’ drug control conventions. Some of the regulations under the Controlled Drugs and Substances Act are relatively new, while others are older. The Narcotic Control Regulations, for example, first came into force in 1961 under the Narcotic Control Act (the legislation that preceded the Controlled Drugs and Substances Act), while the Benzodiazepines and Other Targeted Substances Regulations came into force in 2000 under the authority of the Controlled Drugs and Substances Act.

This evolution has resulted in a set of regulations that, while containing broadly similar provisions, also features issues, gaps and inconsistencies, causing undue burden for the administration of and compliance with these regulations.

Narrative

Health Canada has previously proposed to modernize regulations under the Controlled Drugs and Substances Act through a staged approach, built on a series of thematic regulatory proposals to consolidate the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and Parts G and J of the Food and Drug Regulations into a single new Controlled Substances Regulation.

Review process:

The first step in this initiative was the modernization of provisions pertaining to licences and permits (under the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and Parts G (controlled drugs) and J (restricted drug) of the Food and Drug Regulations). These provisions were modernized in 2019.

As a next step in this modernization initiative, Health Canada intends to consult on a new regulation that will consolidate the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and Parts G (controlled drugs) and J (restricted drugs) of the Food and Drug Regulations into a single new Controlled Substances Regulation. This consolidation is expected to result in a modernization of regulatory language throughout the proposed new regulation. In addition, changes to regulatory provisions pertaining to pharmacists, individuals, destruction and test kits would also be made to:

• Support pharmacy innovation in Canada, and enable pharmacists to more fully use their expertise and contribute to Canada’s responses to urgent and non-urgent health-related situations, while maintaining stewardship over the movement of controlled substances;
• Allow individuals to travel with prescription drugs containing controlled substances for personal medical use and to 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; and,
• Update provisions in relation to test kits.

No substantive changes to the current provisions pertaining to hospitals and practitioners are expected to be made until such a time as the regulatory consolidation has been completed and further consultation with stakeholders has been done.

Coordinating amendments will also be made to other federal regulations, including the Precursor Control Regulations, the Cannabis Regulations, and the Food and Drug Regulations.

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2022 and last 60 days.

The licences and permits, pharmacists, and hospitals components of this modernization initiative were identified by Health Canada as part of its Health and Biosciences Sector Regulatory Review Roadmap.

Date of last review or amendment

Amendments to regulatory provisions pertaining to licences and permits (under the Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, and Parts G and J of the Food and Drug Regulations) were made in 2019.  The amending regulations were published in the Canada Gazette, Part II on June 12, 2019 and came into force on December 9, 2019.

Targeted start for review

2015 (the review is ongoing)

Outcomes

This regulatory modernization initiative is ongoing. The next step is expected to be the publication of a single new consolidated Controlled Substances Regulation for public comment.

Amendments made to the provisions pertaining to licences and permits in 2019 achieved the following outcomes:

• Enhanced clarity and alignment, thereby facilitating compliance with the regulations;
• Reduced administrative burden for licence holders; and,
• Strengthened powers for the Minister to address issues of public health and public safety related to the diversion or problematic use of controlled substances.

Stakeholder feedback

Certain aspects of this modernization initiative have been consulted upon previously, as follows:

• A Notice to Interested Parties seeking feedback on proposed regulatory changes pertaining to the return, destruction of, and travel with controlled substances was published in the Canada Gazette, Part I on October 28, 2017 for a 60-day public comment period;
• A Notice to Interested Parties seeking feedback on proposed regulatory changes pertaining to test kits was published in the Canada Gazette, Part I, on March 31, 2018 for a 60-day public comment period; and,
• A Notice to Interested Parties seeking feedback on proposed regulatory changes pertaining to pharmacists was published in the Canada Gazette, Part I on March 9, 2019 for a 60-day public comment period.

For further information

For further information, please consult Health Canada’s Forward Regulatory Plan, the Health and Biosciences Sector Regulatory Review Roadmap, or additional information can be requested from the departmental contact.

Departmental or agency contact

Jennifer Pelley
Director
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Email:  csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Food and Drug Regulations to modernize the regulation of food to encourage businesses to bring safe and innovative products to market in Canada.

Specifically, the proposed amendments would; (1) create a regulatory framework to enable continued use of Human Milk Fortifiers (complete); (2) modernize the regulations for microbiological safety criteria and methods of analysis for timelier and more efficient revisions to respond to advancing science and technology; (3) streamline food additive rules; and, (4) establish a new regulatory framework for foods supplemented to contain added ingredients like vitamins or caffeine to safely allow them on the Canadian market.

These priority areas are the first steps to implement a modernized and redesigned architecture for food regulations under the Food and Drugs Act.

This regulatory initiative was identified by Health Canada in the Agri-food and aquaculture sector: Targeted regulatory review.

This initiative is linked to the Health Canada / Canadian Food Inspection Agency Joint Policy Statement on Food Labelling Coordination.

Narrative

The proposed amendments would apply to businesses involved in the sale of regulated food products in Canada.

Health Canada would expect these proposals to provide greater clarity and predictability for businesses to allow them to bring food products to market in a timely manner. This impact would in turn provide Canadians with greater, faster access to safe and innovative food products.

Review process:

Heath Canada plans to pre-publish the proposed changes related to microbiological criteria for foods, scientific methods of analysis and food additives in the Canada Gazette, Part I in fall 2022 for a 70-day comment period.

Health Canada plans to publish the amended regulations related to supplemented foods in the Canada Gazette, Part II in spring 2022.

As per the joint Health Canada/Canadian Food Inspection Agency Food Labelling Coordination policy, the target compliance date for the supplemented food amendments is anticipated in January 1, 2026.

Date of last review or amendment

Food and Drugs Act: 2019

Food and Drug Regulations: 2022

Targeted start for review

2021

Stakeholder feedback

Between 2011 and 2020, Health Canada held several targeted consultations on the proposed approach for Human Milk Fortifiers, including on the draft regulations. Health professionals and industry stakeholders were supportive of the overall development of a regulatory framework for these products.

Health Canada engaged stakeholders on the future of food, and on how the entire sector can work collaboratively to provide Canadians with healthy and safe food. The Consultation Summary - Food and Nutrition Stakeholder Engagement Session was published on May 7, 2019.

Health Canada published the amended regulations for Human Milk Fortifiers in the Canada Gazette, Part II on April 14, 2021.

Health Canada received a number of stakeholder submissions representing a wide range of views on the supplemented foods proposal following the publication of proposed changes related to supplemented foods in the Canada Gazette, Part l on June 26, 2021.

For further information

Related information can be found on:

• Event summary: Health Canada's 2021 stakeholder update on food and nutrition, May 6, 2021;
• Regulations Amending the Food and Drug Regulations (Supplemented Foods); and,
• Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers).

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Medical Devices Regulations to enable the implementation of an agile, modern licensing scheme to regulate medical devices throughout the lifecycle of devices. Specifically, the proposed amendments would: (1) improve and maintain medical device safety; (2) enable access to new innovations; and, (3) help support economic growth.

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

Additional notes: Some components of this initiative are included in the initiative entitled Exemptions for Certain Digital software described in the Forward Regulatory Plan - Regulations Amending the Medical Device Regulations (Agile Regulations for Licensing Medical Devices), formerly referred to as Regulations amending the Medical Devices Regulations (Agile Regulations). To ensure regulatory consistency, some components of this initiative will be incorporated into the Regulations Amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs), formerly referred to as Regulations amending the Food and Drug Regulations, Part C (Agile Regulations for Licensing Drugs, including Self-Care Framework Phase 2 and the Use of Foreign Decisions).

Narrative

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

Health Canada would expect potential impacts to include:

• Improved risk-based regulation of medical devices, both before and after they are on the market;
• Increased support for better decision-making by patients, health care practitioners and provinces/territories;
• Reduced pre- and on-market costs for lower risk medical devices; and,
• Increased encouragement for businesses to bring innovative, safe, high-quality medical devices on to the Canadian market.

Review process:

As part of Phase 1 of the proposed Agile Regulations for Licensing Drugs initiative, Health Canada launched a Notice of Intent proposing targeted amendments to the Food and Drug Regulations and Medical Devices Regulations in July 2021.

Health Canada plans to pre-publish the Phase 1 proposed changes in the Canada Gazette, Part I in fall 2022.

Health Canada intends to engage with key stakeholders on other components in 2022. Further details will be made available once plans are finalized.

Health Canada plans to pre-publish the proposed changes for Agile Licensing for Medical Devices in the Canada Gazette, Part I in fall 2023 with a 70-day comment period.

Date of last review or amendment

2019

Targeted start for review

2022

Stakeholder feedback

In 2020 and 2021, Health Canada consulted stakeholders on aspects of this initiative relating to temporary regulations (Interim Orders) for the importation and sale of medical devices for use in relation to COVID-19 pandemic. Stakeholders were generally supportive of the Interim Orders. 

For further information

Related information can be found on:

• Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality;
• Regulatory innovation for health products: Agile licensing for medical devices; and,
• Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is planning to advance Modernizing the Drug Establishment Licensing (DEL) Framework in two phases.

Phase I is targeting fall 2022. The proposed amendments would include components respecting DEL, good manufacturing practices, and recall reporting to take a more agile, risk-based approach to compliance and enforcement oversight for drugs and reduce regulatory and operational burden. The proposed amendments for drugs would:

• Modernize the reporting requirements for voluntary and mandatory drug recalls in a manner that is consistent with existing policy;
• Address outdated references in the DEL framework to other regulatory authorities who participate in mutual recognition agreements with Canada; and,
• Amend the requirements related to confirmatory testing and direct shipping for certain biologic drugs and radiopharmaceuticals (e.g., gene therapy products).

Phase II is targeting fall 2023. The proposed amendments would reduce burden associated with annual licence review and modernize provisions related to the use of compliance and enforcement tools, such as terms and conditions and suspensions. It would introduce less prescriptive and more flexible provisions that would maintain appropriate oversight of regulated activities conducted in Canada.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap under the ‘Establishment licensing scheme for drugs and medical devices’ and ‘Recall reporting expectation’ sections.

Additional notes: This amendment was previously a component of ‘Modernizing Drug and Medical Device Establishment Licensing Frameworks- Amendments to the Food and Drug Regulations and Medical Devices Regulations’ and ‘Recall of Therapeutic Products’ but has now been separated into its own initiative.

Narrative

It is anticipated that the proposal would improve regulatory decision-making efficiency and predictability in relation to DELs, allowing an opportunity for industry stakeholders to streamline compliance programs accordingly.

Review process:

Health Canada has adopted a phased approach for Modernizing Drug Establishment Licensing including the recall of drugs.

Consultations for Phase I

The Modernizing Drug Establishment Licensing Phase I package is targeting pre-publication of amendments to the Food and Drug Regulations in Canada Gazette, Part I in fall 2022.

Consultations for Phase II

The Modernizing Drug Establishment Licensing Phase II package is targeting pre-publication of amendments to the Food and Drug Regulations in Canada Gazette, Part I in fall 2023.

Date of last review or amendment

2018, 2021, 2022

Targeted start for review

2020

Stakeholder feedback

Drug and medical device establishment licence holders were consulted between April and June 2019. 

On December 11, 2021, Health Canada published a Notice of Intent  in Canada Gazette, Part I for a 60-day consultation period. Consultation on Phase I targeted DEL holders, as they are the stakeholders who will be affected by these amendments. The feedback received was minimal but overall generally positive. There were some concerns about the additional recall reporting requirements, and one stakeholder indicated that they would like to see increased flexibility in respect of finished product testing.  

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2022 (Phase I) and fall 2023 (Phase II).

For further information

Related information on drug establishment licensing framework (DEL) can be found on Health Canada’s website.

Additional information can be requested from the departmental contact.

Departmental or agency contact

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Email: prsd-questionsdspr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is planning to advance Modernizing the Medical Device Establishment Licensing Framework in two phases.

Phase I is targeting fall 2022. The proposed amendments to the Medical Devices Regulations would improve and modernize the regulatory oversight of medical devices in Canada. This would be achieved through:

• Streamlining the medical device establishment licence application requirements to reflect existing practices;
• Introducing terms and conditions and the ability to partially suspend or cancel a licence when there is a non compliance; and,
• Giving the Minister the authority to order recalls of medical devices, harmonize the definition of recall and clarify industry-reporting obligations.

Phase II is targeting fall 2023. The proposed amendments to the Medical Devices Regulations would:

• Improve and modernize the regulatory oversight of the medical devices supply chain in Canada. This would be achieved through clarifying uncertainties around importation introduced into the Regulations from the last round of regulatory amendments; and,
• Provide the Minister with additional compliance and enforcement authorities to address issues in a more targeted and strategic manner.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap under the ‘Establishment licensing scheme for drugs and medical devices’ and ‘Recall reporting expectation’ sections.

Additional notes: This amendment was previously a component of both the Modernizing Medical Device Establishment Licensing (MDEL) Framework  and the Modernizing Compliance and Enforcement Oversight for Drugs (establishment licensing, good manufacturing practices, and recalls) and has now been combined into its own initiative.

Narrative

Phase I and II of the proposed Framework would create a level playing field with other jurisdictions for Canada's medical device sector.

It would improve the predictability and efficiency of recalls for industry and decrease the burden on industry relating to the reporting of low risk issues for medical devices. It would also close regulatory gaps by extending regulatory oversight to facilities distributing safe medical devices to the global markets.

Review process:

Health Canada has adopted a phased approach for Modernizing Medical Device Establishment Licensing Framework including the recall of medical devices.

Consultations for Phase I

The Modernizing Medical Device Establishment Licensing Phase I package is targeting pre-publication of amendments to the Medical Devices Regulations in Canada Gazette, Part I in fall 2022.

Consultations on Phase II

Further targeted stakeholder consultations are planned for fall 2022 to inform policy development prior to publication in Canada Gazette, Part I targeted for fall 2023. 

Date of last review or amendment

2018, 2021, 2022

Targeted start for review

2020

Stakeholder feedback

Industry and stakeholders were consulted in 2016.

Drug establishment licence holders and medical device establishment licence holders were consulted between April and June 2019. 

On December 11, 2021, Health Canada published a Notice of Intent in Canada Gazette, Part I, with a 60-day consultation period, to inform stakeholders of the proposed policy direction, and to provide opportunities for comment on the proposed policy approach.

Health Canada held stakeholder consultations targeting MDEL holders in fall 2021/winter 2022 on Phase I of this proposal.  More than 100 industry stakeholders completed the cost-benefit analysis survey and participated in the consultation regarding the proposed amendments. Stakeholders generally supported the proposal.

Canadians will have the opportunity to provide comments on Phase I of the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2022 (Phase I) and fall 2023 (Phase II).

For further information

The Forward Regulatory Plan: Modernizing Medical Device Establishment Licensing Frameworks, Health and Biosciences Sector Regulatory Review Roadmap or additional information can be requested from the departmental contact.

Departmental or agency contact

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Email: prsd-questionsdspr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Natural Health Products Regulations and Food and Drug Regulations to require that natural health products be labelled in a comparable manner to similar self-care products, such as non-prescription drugs, and would introduce a risk-based approach to regulatory oversight for all self-care products.  As the scope of the regulatory proposals is significant, the proposals will be completed in three phases. 

The proposed regulatory amendments would improve the labelling of natural health products (Phase I).

The proposed regulatory amendments would also ensure rules based on level of risk for all self-care products (Phase II and III) as well as simplified market access for non-prescription drug products (Phase II) and continuous improvement of the natural health product regulatory framework (Phase III).

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

Phase I and Phase III would address many recommendations made in the 2021 audit by the Commissioner of the Environment and Sustainable Development.

Additional notes: To ensure regulatory consistency, some components of this initiative (Phase II, Simplified market access for non-prescription drug products) are intended to be incorporated into the Regulations Amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs), formerly referred to as Regulations amending the Food and Drug Regulations, Part C (Agile Regulations for Licensing Drugs, including Self-Care Framework Phase 2 and the Use of Foreign Decisions).

Narrative

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

Health Canada would expect the Phase I proposal to result in Canadians being able to make more informed choices by supporting the safe use of self-care products through improved labelling on natural health products. While businesses may incur costs related to labelling changes, the implementation plan is intended to minimize these impacts to the extent possible.

Phase II would introduce expedited pathways for lower-risk non-prescription drug products, including a class-based licensing system, appropriate pharmacovigilance requirements and establishment licensing that is commensurate with the risk of these products. These changes are intended to decrease regulatory burden and costs to businesses, as well as introduce greater efficiencies for businesses.

Phase III would expand the efficiencies and modernization achieved for non-prescription drugs to natural health products, such as a class-based structure for simplified applications and enhanced premarket quality review, annual notification to identify marketed products, site licensing and good manufacturing practices.

Review process:

Health Canada plans to publish the Phase I proposed changes in the Canada Gazette, Part II in spring 2022.

Date of last review or amendment

Natural Health Products Regulations: 2018

Food and Drug Regulations: 2019

Targeted start for review

2021

Stakeholder feedback

Since the fall of 2016, Health Canada has held a series of public consultations seeking input on modernizing the Department's approach to regulating self-care products.

Summaries of consultations can be found on:

• Report of online consultation on modernizing the regulation of self-care products in Canada; and,
• Consulting Consumers on Self-Care Product Labelling: A Report on What We Heard.

In response to publication in Canada Gazette, Part I on June 26, 2021, Health Canada received a number of stakeholder submissions representing a wide range of views on the Phase I proposal.

For further information

Related information can be found on:

• Self-Care Products;
• Summary: What We Heard on self-care product regulation;
• Consultation on the regulation of self-care products;
• Consulting Consumers on Self-Care Product Labelling: A Report on What We Heard;
• Consultation: Improved labelling for natural health products: Proposed changes to regulations; and,
• Simplified market access to non-prescription drugs (Phase II of the Self-Care Framework).

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email:   lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

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

Specifically, the proposed amendments would: (1) 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; (2) introduce a coherent risk-based approach to the regulation of clinical trials in Canada; (3) afford greater flexibility in the safe development of innovative therapies and products, and innovative clinical trial designs; (4) streamline regulatory processes toward greater efficiency and clarity; and, (5) align with international best practices regarding clinical trial oversight and public access to information.

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

Narrative

The proposed amendments would apply to health and biosciences and agri-food stakeholders involved in the conduct of clinical trials in Canada. 

Health Canada would expect that this regulatory proposal would improve clarity, predictability and transparency around the regulation of clinical trials for businesses, academics and Canadians. Improved agility of the regulatory framework is expected to benefit researchers and industry by better accommodating innovative, non-conventional clinical trial designs; this in turn could benefit Canadians by improving access to clinical trials. The application of a risk-based approach would help reduce regulatory burden for some clinical trials conducted on marketed products.

Canadian participants in trials would benefit from improved safety monitoring. Health care professionals would be able to apply for investigational testing of medical devices (without going through a manufacturer). As well, the agri-food business would be able to conduct clinical trials for infant formula and other foods for a special dietary purpose within Canada.

Review process:

Health Canada plans to pre-publish the proposed changes in the Canada Gazette, Part I in fall 2022 with a 70-day comment period.

Date of last review of amendment

Natural Health Products Regulations: 2018

Medical Devices Regulations: 2019

Food and Drug Regulations: 2019

Targeted start for review

2022

Stakeholder feedback

In response to stakeholder engagement and consultation undertaken in 2019, stakeholders confirmed that having a flexible framework, enabling clinical trials would draw in key companies and investments, and support research and innovation in Canada.

Additional engagement was undertaken in 2020 related to the Interim Order Respecting Clinical Trials for Medical Devices and Drugs relating to COVID-19 that has similar regulatory approaches to those in this proposal. Stakeholders were generally supportive of the proposal to transition the Interim Order into regulations.

In spring 2021, Health Canada launched two related and parallel consultations to seek stakeholder feedback. 

1. One consultation sought stakeholder feedback on the modernization of the clinical trial framework for drugs, devices and natural health products.

   Health Canada published a What We Heard Report on February 23, 2022 on the consultations that were conducted in the spring and summer of 2021. Stakeholders provided 122 written submissions and close to 1,000 stakeholders participated in eight interactive webinar sessions.

2. The other consultation sought stakeholder feedback on the design and development of regulations that would enable the authorization and conduct of human clinical trials in Canada regarding foods for a special dietary purpose.

   Health Canada published the Consultation summary: Clinical trial regulations for foods for a special dietary purpose on February 23, 2022. Stakeholders provided five written responses and participated in an interactive webinar to clarify questions.

Overall, most stakeholders were supportive of these initiatives.

For further information

Related information can be found on:

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

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing amendments to the Food and Drug Regulations to implement an agile, modern licensing scheme for drugs (prescription and over-the-counter) in Canada.

Specifically, the proposed amendments would: (1) implement agile regulations that support timely access to innovative drugs; (2) enable regulatory oversight based on risk and evolving evidence; (3) harmonize and align internationally; and, (4) improve transparency about the risks, benefits and uncertainties of drugs. 

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap and the Agri-food and Aquaculture Regulatory Review Roadmap.

Additional notes: This initiative was previously entitled: Regulations amending the Food and Drug Regulations, Part C (Agile Regulations for Licensing Drugs, including Self-Care Framework Phase 2 and the Use of Foreign Decisions).

To ensure regulatory consistency, this initiative intends to incorporate components of the following initiatives included in these Forward Regulatory Plans:

• Regulations Amending the Food and Drug Regulations (Use of Foreign Decisions);
• Regulations Amending the Natural Health Products Regulations and the Food and Drug Regulations (Self-Care Framework) [formerly referred to as Self-Care Framework]; and,
• Regulations Amending the Medical Devices Regulations (Agile Regulations for Licensing Medical Devices) (formerly referred to as Regulations amending the Medical Devices Regulations (Agile Regulations).

Narrative

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

Health Canada would expect potential impacts to include improved risk-based regulation of drugs, both before and after they are on the market; increased support for better decision-making by patients, health care practitioners and provinces/territories; simplified market access for over-the-counter drugs and increased encouragement for businesses to bring innovative, safe, high-quality drugs on to the Canadian market.

Review process:

As a result of the significant scope of the proposed regulatory amendments proposed, Health Canada intends to proceed in several phases, each composed of one or more regulatory proposals, over the next few years.

Health Canada plans to pre-publish the Phase 1 proposed changes in the Canada Gazette, Part I in fall 2022.

Date of last review or amendment

Food and Drug Regulations: 2019

Targeted start for review

Food and Drug Regulations: 2022

Stakeholder feedback

In 2020 and 2021, Health Canada consulted stakeholders on aspects of this initiative relating to temporary regulations (Interim Orders) and the transition of those aspects to a permanent regulatory framework. Components of the temporary and permanent regulatory proposals are similar regulatory approaches in this proposal:

• Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19;
• Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19; and,
• Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19).

As part of Phase 1 of the proposed Regulations Amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs), Health Canada launched in July 2021 a Notice of Intent proposing targeted amendments to the Food and Drug Regulations and Medical Devices Regulations.  Stakeholder feedback on the proposed amendments was generally positive. Particular support was expressed for Health Canada’s efforts towards regulatory modernization in general to reduce regulatory irritants, improve access to therapeutic products, and enhance post-market oversight throughout the lifecycle of a drug or device. The feedback from stakeholders will be taken into consideration as part of the regulatory package development for Canada Gazette, Part I.

For further information

Related information can be found on:

• Improving the regulatory review of drugs and devices;
• Regulatory innovation for health products: Agile licensing for drugs;
• Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders;
• Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19; and,
• Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19).

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Hazardous Products Act

Rationale

Health Canada is proposing amendments to the Hazardous Products Regulations and Schedule 2 of the Hazardous Products Act to align with the seventh revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

The objectives of the amendments are to incorporate changes adopted in the sixth and seventh revised editions of the GHS, and to amend certain provisions of the regulations to provide greater clarity.

Narrative

Health Canada is proposing amendments to the Hazardous Products Regulations to incorporate changes adopted in the sixth and seventh revised editions of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). These changes will provide greater clarity, and maintain alignment between Canada and the United States hazard classification and communication requirements for workplace chemicals.

Schedule 2 to the Hazardous Products Act will also be amended to reflect the required changes to the hazard classes under the Hazardous Products Regulations, which will primarily be based on the seventh revised edition of the GHS.

This regulatory initiative will strengthen worker health and safety protections.

Review process:

The amending regulations are expected to be published in the Canada Gazette, Part ll in fall 2022.

Date of last review or amendment

Sections 4.4.1 and 4.5 of the Hazardous Products Regulations were amended in April 2018.

Targeted start for review

2018

Stakeholder feedback

The regulatory proposal was pre-published in the Canada Gazette, Part I on December 19, 2020, for a 70-day public comment period.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Lynn Berndt-Weis
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email address: whmis-simdut@hc-sc.gc.ca

Enabling act

Pest Control Products Act

Rationale

Health Canada plans to undertake the first comprehensive review of the Pest Control Products Regulations since its coming into force.

Narrative

Health Canada has developed a multi-year plan to review the Pest Control Products Regulations. The objectives of the review are to:

• Ensure that the Pest Control Products Regulations are current and reflective of the Pest Control Products Act, taking into account the statutory review of the Pest Control Products Act; Ensure the Pest Control Products Regulations continue to meet policy objectives, while attempting to minimize regulatory burden on regulatory parties; and,
• Provide recommendations on policy, program, and regulatory actions required to address identified issues.

This review includes the following initiatives that were identified in the Agri-food and Aquaculture Sector Regulatory Review Roadmap:

• Label modernization for pest control products: These proposed amendments would permit the use of electronic labels and internationally aligned Globally Harmonized System standards, and measures to improve the readability of labels;
• Modernize authorization process for certain pest control products for which registration is not required: These proposed amendments would exempt certain pest control products (e.g., devices, pool and spa products, and “food on food” products) from the registration requirements under the Pest Control Products Act;
• Data protection modernization for pest control products: These proposed amendments would clarify for regulated parties how the data protection program works in the post-market context, and would reduce the effort required to administer it; and,
• Modernize the post-market review process for pest control products: This review of the re-evaluation program is complete. Based on the review, Health Canada has launched a multi-year program renewal project to build a stronger, effective and efficient pesticide regulatory program that improves health and environmental protection and leads to improved timeliness of scientific decisions.

Date of last review or amendment

The Pest Control Products Regulations were amended in 2020, with changes pertaining to certain chemicals listed in Schedule 2 (“Regulations Amending the Pest Control Products Regulations (Sodium Bromide and Potassium Monopersulfate): SOR/2020-263”).

Targeted start for review

2016

Stakeholder feedback

Stakeholders have been engaged on each of the initiatives described above via the Treasury Board of Canada Secretariat led Targeted Regulatory Review of the Agri-food and Aquaculture Sectors and other mechanisms (e.g., webinars, published consultation documents, face-to-face meetings). Their feedback has and continues to inform work on the review and recommendations flowing from it.

Proposal to modernize the authorization process for certain pest control products for which registration is not required: Health Canada consulted on the proposal to remove sodium bromide and potassium monopersulfate from Schedule 2 of the Pest Control Products Regulations to address unacceptable health risks through:

• Proposed Re-evaluation Decision “PRVD2017-10, Sodium Bromide” (2017), and,
• A regulatory proposal document “PRO2018-03 Consultation on Proposed Amendments to the Pest Control Products Regulations (Product Exemptions)” (2018).

In both cases, no comments were received on the proposal.

Project to modernize the post-market review process for pest control products: From February to September 2020, Health Canada engaged stakeholders from across Canada to hear their views regarding proposed changes to the pesticide evaluation program. Stakeholder feedback was summarized in a “What Was Heard” report published in April 2021. Stakeholders were generally in favour of the proposed changes, and their feedback has informed continued development of program renewal activities.

Outcomes

This regulatory modernization initiative is ongoing.

Proposal to modernize the authorization process for certain pest control products for which registration is not required: Certain aspects of this proposal are complete, and amended. Amendments made to Schedule 2 of the Pest Control Products Regulations, which is used to exempt certain products from registration, provided regulatory clarity that sodium bromide and potassium monopersulfate are not authorized products.

For further information

For further information, please consult:

• Health Canada’s Forward Regulatory Plan;
• Health Canada’s Re-evaluation Program web page; and,
• The Targeted Regulatory Review: Agri-food and Aquaculture Roadmap.

Additional information can be requested from the departmental contact.

Departmental or agency contact

Jordan Hancey
Director
Policy and Operations Directorate
Pest Management Regulatory Agency
Email:  pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Enabling act

Radiation Emitting Devices Act

Rationale

Health Canada is proposing amendments to the Radiation Emitting Devices Regulations pertaining to lasers, to address health risks and injuries to Canadians from these products.

The proposed amendments would align Canada's regulations with international standards, specifically the International Electrotechnical Commission’s "IEC 60825-1, Safety of Laser Products - Part 1: Equipment classification and requirements, Ed. 3.0, 2014”. Canada’s key trading partners use and reference this standard.

Narrative

The amended regulations would enhance the safety of laser products imported, sold, leased and advertised in Canada by requiring appropriate laser warning labels and establishing minimum design safety features for specific laser classes/hazard levels.

Review process:

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in fall 2022 and last 75 days.

Date of last review or amendment

The Radiation Emitting Devices Regulations represents one regulatory title comprised of a series of parts related to different devices.

Parts VII (Laser Scanners) and VIII (Demonstration Lasers) of Schedule II of the Radiation Emitting Devices Regulations were both introduced in 1977.  Part VII was substantively amended in 1985. In 2018, a minor amendment was made to this regulation via a Miscellaneous Amendment Regulations (MAR) to correct a negative sign to a positive sign. Part VIII was last amended in 1981.

Targeted start for review

2020

Stakeholder feedback

Health Canada undertook an online public consultation process on this proposal from June 30, 2021, to August 30, 2021.

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

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

Enabling act

Canadian Environmental Protection Act, 1999

Rationale

Health Canada is proposing amendments to the Formaldehyde Emissions from Composite Wood Products Regulations to clarify quality control testing requirements and the Declaration of Certification record-keeping requirements.

Narrative

Health Canada is proposing amendments to section 17 of the Formaldehyde Emissions from Composite Wood Products Regulations to clarify quality control testing requirements and to review the Declaration of Certification record-keeping provisions of the regulations.

Review process:

Health Canada is holding discussions with key stakeholders, and Canadians will have the opportunity to provide comments on the proposed regulatory amendment during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2023 and last 75 days.

Date of last review or amendment

The Formaldehyde Emissions from Composite Wood Products Regulations were published in Canada Gazette, Part II on July 7, 2021.

Targeted start for review

2022

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

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

Enabling act

Food and Drugs Act

Rationale

Health Canada is proposing to introduce a requirement under the Cosmetic Regulations for the disclosure of certain fragrance allergens on the product label. In addition, Health Canada is proposing to amend the regulations to enhance regulatory oversight for cosmetics.

The amended regulations would inform consumers about the presence of certain fragrance allergens, outside of the term “parfum”, that are present in the product. This would allow consumers to avoid products containing fragrance allergens to which they may be sensitive.

Narrative

Health Canada is proposing amendments to the Cosmetic Regulations to:

• add a requirement to disclose certain fragrance allergens on the labels of cosmetics;
• provide a flexible option for the disclosure of ingredients for cosmetics that are available in small packages;
• improve the oversight of cosmetics by:
  • clarifying terminology and improving the level of detail in the information submitted in a cosmetic notification;
  • enhancing compliance and enforcement tools through additional authorities and expanded responsibilities of importers; and,
• address administrative changes.

For fragrance allergens, the proposal would align Canada’s requirements with other international regimes (e.g., European Union).

Review process:

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I public comment period, which is expected to take place in summer 2022 and last 70 days.

Date of last review or amendment

These regulations were significantly amended in 2004 (ingredient disclosure on product labels).

Targeted start for review

2021

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: cosmetics@hc-sc.gc.ca

Enabling Act

Food and Drugs Act

Rationale

Health Canada is proposing to add a description of adaptive Machine Learning-enabled Medical Devices (MLMD) to Schedule G of the Food and Drugs Act, thereby allowing them to be regulated as Advanced Therapeutic Products, given the innovative nature of the adaptive devices. 

The current Medical Devices Regulations framework cannot appropriately accommodate adaptive MLMD since these devices change post-authorization in real-world settings in response to new inputs. The Advanced Therapeutic Products pathway will allow Health Canada to authorize adaptive MLMD while tailoring pre- and post-market requirements, specific to an adaptive MLMD’s unique characteristics, to maintain high standards for patient safety, product quality, and effectiveness.

The proposed addition to Schedule G of the Food and Drugs Act would: (1) enable access to these important, complex, and unique technologies, which are expected to positively impact the health of Canadians, while providing regulatory assurances of safety, effectiveness, and quality; (2) support Canada’s competitiveness in this sector; and, (3) enable Health Canada to adapt oversight requirements, iteratively with domestic and international stakeholders, and use this to inform future regulatory approaches.

This regulatory initiative was identified by Health Canada in the Health and Biosciences Sector Regulatory Review Roadmap.

Narrative

The proposed addition to Schedule G of the Food and Drugs Act would apply to stakeholders involved in various activities related to adaptive MLMD, such as import, manufacturing, sale, etc.

Health Canada would expect this proposal to create a pathway under which persons could bring adaptive MLMD to the Canadian market, while protecting health and safety, resulting in benefits to Canadians from access to new and advanced healthcare technologies, such as medical devices that learn in real-time to deliver, for example, more precise medical imaging results.

Review process:

External stakeholder engagement will be accomplished through a multi-pronged approach including an external reference group, targeted meetings, networking, webinars and relevant website communications in 2021 and 2022. Broader stakeholder engagement will be held as part of the implementation of the Advanced Therapeutic Products pathway and concierge service.

Canadians will have the opportunity to provide comments on the proposal when the anticipated Notice of Intent is published in Canada Gazette, Part I, in spring 2022.  

Date of last review or amendment

2019

Targeted start for review

2021

For further information

Background information on the Advanced Therapeutic Products initiative:

• Advanced Therapeutic Products section of the Health and Bioscience Review; and,
• Regulatory Innovation page for Advanced Therapeutic Products.

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling act

Food and Drugs Act

Rationale

The proposed regulations and the regulatory amendments to the Food and Drug Regulations, the Natural Health Products Regulations and the Pest Control Products Regulations would ensure a harmonized and flexible approach to the regulation of biocides (surface disinfectants and surface sanitizers). Currently, these are regulated under separate regimes, creating challenges for industry and regulators, acutely experienced during COVID-19. 

Specifically, the proposed amendments would: (1) create one comprehensive framework for the regulation of biocides; (2) enable regulatory oversight based on risk and evolving evidence; and, (3) introduce a use of foreign decisions pathway.

Additional note: Previously named Regulations amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and surface sanitizers).

Development of this initiative has been a part of broader work on modern regulations related to the Health and Biosciences Sector Regulatory Review Roadmap.

Narrative

The proposed regulations would apply to businesses involved in the sale of biocide products in Canada.  

Health Canada would expect this proposal to reduce barriers and create efficiencies for businesses wanting to bring biocides to the Canadian market, resulting in timely access to biocides for Canadians. Benefits may vary between companies.

Review process:

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, as part of future phases of Agile Regulations for Licencing Drugs.

Date of last review or amendment

2022

Targeted start for review

2018

For further information

Related information can be found on this web page: Use of foreign reviews and decisions.

Additional information can be requested from the departmental contact.

Departmental or agency contact

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Enabling Act

Food and Drugs Act

Rationale

The proposed regulatory amendments to the Food and Drug Regulations would create a streamlined application pathway that allows manufacturers of certain drugs that address an unmet medical need to rely on the authorization of a trusted foreign regulator.

Key objective:

Facilitate access to certain drugs (human and veterinary) that address an unmet medical need.

Key linkages:

This regulatory initiative aligns with the Government’s commitment to provide more timely access to drugs and devices through the Regulatory Review of Drugs and Devices.

This regulatory initiative was identified by Health Canada in the Agri-food and Aquaculture Sector Regulatory Review Roadmap and the Health and Biosciences Sector Regulatory Review Roadmap.

Additional notes: To ensure regulatory consistency, this initiative has been incorporated into the Regulations amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs) initiative. 

Narrative

The proposed amendments would apply to businesses seeking authorization to sell drugs that address an unmet medical need in Canada.

Health Canada would expect potential impacts to include reduced authorization costs providing an incentive for manufacturers to bring their product to the Canadian market. This in turn, would facilitate access to medically necessary drugs that are not readily available to Canadians. The proposed amendments would also create a pathway that would enable access by veterinarians, animal owners and food producers to minor use, minor species veterinary drugs that have not come to the Canadian market.

Review Process:

Health Canada plans to pre-publish the proposed changes in the Canada Gazette, Part l in fall 2023 (TBC) with a 70-day comment period.

Stakeholder engagement and consultation have been ongoing since 2017, including as part of the Health Canada’s emergency regulatory response to the COVID-19 pandemic.

Date of last review or amendment

2022

Targeted start for review

2018

For further information

Related information can be found on this web page: Use of foreign reviews and decisions.
Additional information can be requested from the departmental contact.

Departmental or agency contact:

Bruno Rodrigue
Executive Director
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca