Health Canada's Regulatory Stock Review Plan: 2021 - 2023

The Regulatory Stock Review Plan is a public list and description of planned reviews of regulations that Health Canada is proposing within a two-year period. It is intended to give Canadians, including businesses, Indigenous Peoples, and international partners greater opportunity to inform the reviews of regulations and to plan for the future.

In Budget 2018, the Government announced a regulatory reform agenda focused on supporting innovation and encouraging economic growth. Targeted sectoral reviews were completed in the health and biosciences, agri-food and aquaculture, and transportation and infrastructure sectors. Health Canada participated in the regulatory reviews targeting the health and biosciences and the agri-food and aquaculture sectors.

Through these reviews, the department planned initiatives to address the issues and irritants identified by stakeholders in the regulatory reviews conducted in 2019 and 2020. These initiatives were described in the 2018 Health and Biosciences Sector Regulatory Review Roadmap, and the Agri-food and Aquaculture Sector Regulatory Review Roadmap. These initiatives form the basis of the department's 2021 - 2023 stock review plan.

The stock review plan identifies a departmental contact point for the planned reviews. If stakeholders wish to provide comments on a specific review, they can contact the responsible branch by using the information listed. For general inquiries on the stock review plan, please contact Health Canada's Departmental Regulatory Affairs Section at hc.dra-arm.sc@canada.ca. The stock review plan will be adjusted and updated over time to reflect Health Canada's regulatory priorities and changes to the operating environment.

Completed Reviews

Regulations amending the Food and Drug Regulations (Finished Product Testing)

Enabling Act

Food and Drugs Act

Rationale

The key objectives of this review are to:

This proposal addressed a longstanding regulatory irritant for industry for lower risk products imported from countries having a comparable GMP compliance program to Canada.

Narrative

The proposal created a new exemption under the Food and Drug Regulations, which relieved Canadian importers and manufacturers from testing requirements for certain imported products prior to being sold in Canada, and allowed importers to ship finished products directly to retailers, distributors, and wholesalers in Canada.

Where testing requirements are already met in a foreign country with a comparable GMP compliance program to Canada, and by an establishment meeting Canada's GMP requirements, this proposal eliminated costs associated with the retesting and quarantine of finished products imported into Canada. This also provided industry with flexibility to streamline its distribution networks and save on operational costs. Finally, this proposal enabled Canadians to have faster access to exempted products and allow businesses to pass on cost savings to Canadian consumers without compromising the safety and efficacy of imported products.

Date of last review or amendment

2018

Targeted start for review

2019

Stakeholder Feedback

The issue was first raised as part of the consultations conducted under the umbrella of the Canada-U.S. Regulatory Cooperation Council. As part of the Canada-U.S. Regulatory Cooperation Council Work Plan, Canada launched the Sunscreen Pilot Project under which Health Canada exempted qualifying importers from duplicative re-testing requirements for imported sunscreens approved for sale in Canada through policy. In addition to the consultations conducted under the Canada United States Mexico Agreement, Health Canada also engaged on these amendments as part of the proposed self-care framework, and most recently, as part of the Health and Biosciences Sectoral Regulatory Review.

Outcomes

The review is complete. The resulting amendments to the Food and Drug Regulations were published in Canada Gazette, Part II on April 29, 2020. The amendments came into force on July 1, 2020 with the coming into force of the Canada-United States-Mexico Agreement.

The amendments removed requirements for re-testing and quarantine of imported low-risk cosmetic-like products from certain recognized countries and regions (including mutual recognition agreement partners).

The amendments are expected to achieve the following outcomes:

  • An increase in consumer choice for these products,
  • A reduction in unnecessary regulatory differences; and,
  • A reduction in regulatory burden to industry, while the health and safety of Canadians continues to be protected.

For further information

Contact the departmental contact listed below.

Departmental or agency contact:

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

Regulations Amending the Hazardous Products Regulations, Regulations Amending the Hazardous Materials Information Review Regulations and Repealing the Hazardous Materials Information Review Act Appeal Board Procedures Regulations

Enabling Acts

Hazardous Materials Information Review Act

Hazardous Products Act

Rationale

Consequential amendments to the Hazardous Products Regulations, the Hazardous Materials Information Review Regulations and the repeal of the Hazardous Materials Information Review Act Appeal Board Procedures Regulations were required to align with the amendments to the Hazardous Materials Information Review Act that received Royal Assent on June 21, 2019.

As the regulatory amendments were consequential to the legislative changes, no new regulatory requirements were being introduced.

Narrative

The modernization of the Hazardous Materials Information Review Act was part of the Health and Biosciences Sectoral Regulatory Review and was included in the Budget Implementation Act, 2019, No. 1.

A partial review was conducted to align the Hazardous Products Act and Hazardous Materials Information Review Regulations affected by the modernization of the Hazardous Materials Information Review Act. The regulatory development and analysis were conducted from August 2019 to December 2019.

Workplace Hazardous Materials Information System stakeholders (WHMIS) and partners were consulted on three different occasions through the WHMIS Current Issues Committee and the Intergovernmental WHMIS Coordinating Committee.

Date of last review or amendment

A full review of the Hazardous Products Regulations was conducted in February 2015 to align the Hazardous Materials Information Review Regulations and the Hazardous Materials Information Review Act Appeal Board Procedures Regulations with Workplace Hazardous Materials Information System 2015. Sections 4.4.1 and 4.5 of the Hazardous Products Regulations were amended in April 2018.

Targeted start for review

2019

Stakeholder Feedback

Stakeholders expressed overall support for the modernization of the Hazardous Materials Information Review Act and, where possible, their feedback was incorporated into the amendments of the Hazardous Materials Information Review Act that received Royal Assent on June 21, 2019, via the Budget Implementation Act, 2019, No.1.

The regulatory amendments were needed because of the legislative amendments to the Hazardous Materials Information Review Act.

Outcomes

The review is complete.

The regulatory amendments were published in Canada Gazette, Part II in March 2020 ("Regulations Amending the Hazardous Products Regulations: SOR/2020-38", "Regulations Amending the Hazardous Materials Information Review Regulations and Repealing the Hazardous Materials Information Review Act Appeal Board Procedures Regulations: SOR/2020-39").

The amendments achieved the following outcomes:

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
Health Canada
Email address: hc.whmis-simdut.sc@canada.ca

Regulations Amending the Pest Control Products Incident Reporting Regulations

Enabling Act

Pest Control Products Act

Rationale

A review of these regulations was initiated to identify areas for improvement, based on internal program evaluation and interaction with industry stakeholders.

Narrative

The amendments clarified incident reporting requirements, reduced regulatory and administrative burden, facilitated the Pest Management Regulatory Agency's ability to identify trends and analyze data, and addressed stakeholders' concerns.

This initiative was identified in the Agri-food and Aquaculture Sector Regulatory Review Roadmap.

Date of last review or amendment

2019

Targeted start for review

2015

Stakeholder Feedback

Industry stakeholders were consulted on the review, its findings and the subsequent amendments over several years, and their feedback was taken into consideration in preparing the amendment. Industry associations were generally supportive of the amendments.

Outcomes

The review is complete.

The resulting amendments were published in Canada Gazette, Part II on June 12, 2019.

The amendments achieved the following outcomes:

  • Regulatory requirements are easy to understand;
  • Regulatory and administrative burden is reduced;
  • Trend analysis of incident data is further supported; and
  • Stakeholders' concerns are addressed.

For further information

Information on the Incident Reporting Program can be found online.

Departmental or agency contact:

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

Ongoing Reviews

Modernization of Regulations under the Controlled Drugs and Substances Act

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

Enabling Act

Controlled Drugs and Substances Act

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 feature 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 with a view to eventually consolidating 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.

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 will 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 will also be made in order 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.

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)

Stakeholder Feedback

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.

Outcomes

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.
  • 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 contact the departmental contact listed below

Departmental or agency contact:

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

Modernize food regulations to enable innovative and safe foods for Canadians

Enabling Act

Food and Drugs Act

Rationale

The structure of the current food regulations can prevent industry from bringing safe and innovative products to market due to either out of date regulations or lack of a regulatory structure to permit new products.

Creating a food regulatory system that is more responsive to advances in technology, changing science, and consumer preference would provide greater clarity and predictability for industry to bring products to market in a timely manner and ensure that food regulations are kept up to date and relevant.

Narrative

Health Canada proposes to address this issue by modernizing the regulations for foods under the Food and Drugs Act through an incremental process that will first address the following priority areas:

  • Creating a regulatory framework in the Food and Drug Regulations to enable the continued use of Human Milk Fortifiers (HMFs). HMFs are foods that are added to human milk to increase its nutritional value to meet the particular needs of infants born prematurely or of term infants as medically required;
  • Modernizing the regulations for microbiological safety criteria and methods of analysis to facilitate timelier and efficient revisions in response to emerging science and technology;
  • Streamlining food additive provisions, and
  • Establishing a new regulatory provision for supplemented foods to mitigate potential risks associated with their consumption.

These priority areas will be integrated into a broader initiative to implement a modernized and redesigned architecture for the food regulations under the Food and Drugs Act.

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

Consultations on Human Milk Fortifiers:

  • Health Canada has consulted with stakeholders on the development of a regulatory framework for human milk fortifiers from 2011 to 2014.
  • Further pre-consultations with stakeholders were undertaken throughout fall 2019 and early 2020 as well as additional targeted consultations on draft regulatory language in early fall 2020.
  • Health Canada is seeking to formalize a regulatory framework for human milk fortifiers in spring 2021.

Consultations on Health Canada's microbiological criteria for foods, scientific method of analysis and food additive related changes:

  • 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 2021.

Consultations on Supplemented Foods:

  • Health Canada held pre-consultations with stakeholders on the proposed regulatory framework for supplemented foods ahead of pre-publication in Canada Gazette, Part l. These pre-consultations took place in fall 2020.

In addition, 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 2021.

Date of last review or amendment

Food and Drugs Act: 2019

Food and Drug Regulations: 2019

Targeted start for review

2021

For further information

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: hc.lrm-mlr.sc@canada.ca

Regulations amending the Food and Drug Regulations and Natural Health Products Regulations (Reduction of Records Retention Requirements for Clinical Trials of Drugs Involving Humans)

Enabling Act

Food and Drugs Act

Rationale

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

Reducing the records retention period would decrease the regulatory burden on businesses conducting clinical trials in Canada and could contribute to encouraging this sector to conduct more trials in Canada, and develop new innovative or generic drugs for the Canadian market.

Narrative

Health Canada proposes to reduce the current records retention requirement in the Food and Drug Regulations, and the Natural Health Products Regulations, from 25 years to a minimum of 15 years, with certain exceptions, for all clinical trials of drugs 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.

This proposal would better align the records retention requirement in Canada with international standards and requirements prescribed by other health regulators in countries such as the United Kingdom, the European Union, the United States, and Australia.

Policy consultations and stakeholder engagement on the proposed measures took place in fall 2020. Health Canada also published a Notice of Intent in Canada Gazette, Part I on December 12, 2020. The Notice of Intent informed stakeholders of the proposed policy direction and confirmed that the proposed amendments reflect stakeholders' needs while still offering an appropriate level of protection for Canadians. The comment period closed on January 26, 2021. Further targeted stakeholder consultations occurred in March 2021 to better understand potential risks to patient safety posed by a lower records retention period.

Date of last review or amendment

2001 (last amended)

2018, 2020 (last reviewed)

Targeted start for review

2021

For further information

Forward Regulatory Plan Alignment of Clinical Trial Records Retention Timelines or contact the departmental contact listed below.

Departmental or agency contact:

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

Modernizing Medical Device Establishment Licensing Framework including the recall of medical devices (formerly referred to as Modernizing Drug and Medical Device Establishment Licensing Frameworks - Amendments to the Food and Drug Regulations and Medical Devices Regulations)

Enabling Act

Food and Drugs Act

Rationale

Health Canada's proposed amendments to the Medical Devices Regulations would improve and modernize the regulatory oversight of medical devices in Canada. This would be achieved through:

  • Providing proactive oversight of the fabrication of medical devices solely for the purpose of exportation and transhipment of medical devices in Canada;
  • Streamlining the operations of the Medical Devices Establishment Licensing program, while granting the Minister new compliance and enforcement authorities;
  • Clarifying uncertainties around importation introduced into the regulations from the last round of regulatory amendments; and
  • Improving the effectiveness of recalls in Canada by granting the Minister the authority to issue recalls of medical devices, clarify existing obligations for industry, and harmonizing the definition of recalls.

The proposed amendments would also introduce terms and conditions for Medical Device Establishment Licences.

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' section.

Note: This review was previously a component of 'Modernizing Drug and Medical Establishment Licencing Frameworks - Amendments to the Food and Drug Regulations and Medical Device Regulations' and 'Regulations Amending the Food and Drug Regulations and Medical Device Regulations- Recall of Therapeutic Products' and is now referred to Modernizing Medical Device Establishment Licensing Framework.

Narrative

Modernizing Canada's regulatory requirements for exports and goods in transit would contribute to meeting Canada's obligations under the Canada-European Union Comprehensive Economic Trade Agreement and the World Trade Organization Trade Facilitation Agreement.

This proposal also addresses Canada's Economic Strategy Tables recommendations to adopt requirements that align with international best practices.

This proposal would align Canadian requirements for medical device recalls with the U.S., which would support regulatory harmonization for medical devices under the Canada-United States Regulatory Cooperation Council.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sectoral Regulatory Review Roadmap.

Drug establishment and medical device establishment licence holders were broadly surveyed in 2016, and between April and June 2019. Health Canada intends to undertake a stakeholder consultation process on this proposal prior to Canada Gazette, Part I, publication.

Consultations are expected to begin in spring 2022 in Canada Gazette, Part I.

Date of last review or amendment

2018

Targeted start for review

2020

For further information

The Forward Regulatory Plan: Modernizing Medical Device Establishment Licensing Frameworks, Health and Biosciences Sector Regulatory Review Roadmap or contact the departmental contact listed below.

Departmental or agency contact:

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

Modernizing Compliance and Enforcement Oversight for Drugs (establishment licensing, good manufacturing practices, and recalls) (formerly known as Modernizing Drug Establishment Licensing Framework)

Enabling Act

Food and Drugs Act

Rationale

Health Canada's proposed amendments to the Food and Drug Regulations would streamline requirements for drug establishment licence applications and introduce flexible risk-based elements to the licensing framework. 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.

This proposal would also extend the Drug Establishment Licences Framework to introduce requirements for persons responsible for drug recalls under the Food and Drugs Act.

The Protecting Canadians from Unsafe Drugs Act (also known as Vanessa's Law), gives the Minister of Health the ability to remove a drug by ordering a recall when the product presents an imminent or serious risk to health. Proposed amendments to the Food and Drug Regulations are needed to set out reporting obligations for recalls of drugs conducted pursuant to an order issued by the Minister of Health so that the Department obtains the information necessary to oversee recalls effectively.

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' section.

Note: This review was previously a component of 'Modernizing Drug and Medical Establishment Licencing Frameworks - Amendments to the Food and Drug Regulations and Medical Device Regulations' and 'Regulations Amending the Food and Drug Regulations and Medical Device Regulations- Recall of Therapeutic Products' and is now referred to Modernizing Drug Establishment Licensing Framework.

Narrative

Modernizing Canada's drug establishment licencing framework is expected to increase regulatory decision-making efficiency and predictability in relation to drug establishment licences, allowing an opportunity for industry stakeholders to streamline their compliance programs accordingly.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sectoral Regulatory Review Roadmap.

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

Consultations are expected to begin in spring 2022 in Canada Gazette, Part I.

Date of last review or amendment

2018

Targeted start for review

2020

For further information

The Forward Regulatory Plan: Modernizing Medical Device Establishment Licensing Frameworks, Health and Biosciences Sector Regulatory Review Roadmap or contact the departmental contact listed below.

Departmental or agency contact:

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

Regulations amending the Medical Devices Regulations (Agile Regulations)

Enabling Act

Food and Drugs Act

Rationale

Health Canada is proposing to amend the Medical Devices Regulations to implement an agile, modern licensing scheme to effectively regulate medical devices throughout the life of the device.

Narrative

This initiative is intended to address stakeholder comments that the current licensing system for most health products is rigid and hard to understand.

The ability to place terms and conditions on product approvals will be amended such that information could be further gathered and other measures implemented post-market and used to adjust a licence as appropriate. Additionally, it is proposed to include provisions to leverage foreign reviews and decisions by other trusted foreign regulators.

Health Canada will also explore if adjustments are needed to improve the medical device classification system for lower-risk products.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sectoral Regulatory Review Roadmap.

Consultations are expected to begin in fall 2022 in Canada Gazette, Part I.

Date of last review or amendment

2019

Targeted start for review

2022

For further information

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: hc.lrm-mlr.sc@canada.ca

Self-Care Framework

Enabling Act

Food and Drugs Act

Rationale

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sectoral Regulatory Review Roadmap, which addresses stakeholder comments suggesting a disparity between the regulation of cosmetics, natural health products and non-prescription drugs.

Narrative

Health Canada will update its approach to regulating self-care products based on extensive consultations over recent years.

The Self-Care Framework will roll out in phases over the coming years:

  • Phase I - Targeting spring 2021: Introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve the labelling of natural health products (NHPs). This proposal will require essential risk information to be presented in a standardized format, with minimum font size and black-on-white contrast, making it easier to read, understand and compare with other similar self-care products, such as non-prescription drugs, on store shelves. The use of plain language will also ensure that Canadians can easily understand information on labels.
  • Phase II - Targeting spring 2022: Targeted amendments to introduce, for consultation, a risk-based approach to regulatory oversight for non-prescription drugs. These include expedited pathways for lower-risk products. These changes are intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk. (Associated with Modernizing Drug Establishment Licensing Framework).
  • Phase III -Introduce, for consultation, regulatory amendments to address: evidence standards for similar health claims, extending risk-based regulatory oversight and seeking additional powers for Health Canada, such as the ability to require a recall or label change for all self-care products.

Canadians will have the opportunity to provide comments on Phase I of the Self-Care Framework during the Canada Gazette, Part I public comment period, which is expected to take place in spring 2021.

Date of last review or amendment

Natural Health Products Regulations: 2018

Food and Drug Regulations: 2019

Targeted start for review

2021

For further information

For latest developments and updates to the proposal, please visit the Self-Care Products web page.

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: hc.lrm-mlr.sc@canada.ca

Modernization of the Regulation of Clinical Trials

Enabling Act

Food and Drugs Act

Rationale

Health Canada is proposing to amend sections of the Food and Drug Regulations, Natural Health Products Regulations and the Medical Devices Regulations.

This proposal intends to better align Health Canada's clinical trials framework across its business lines (human drug clinical trials, medical device investigational testing, non-prescription drugs and natural health product clinical trials and food clinical trials), and better align Canada with global best practices regarding oversight and public access to information on clinical trials.

Narrative

The proposed regulatory amendments would: introduce a coherent risk-based approach; afford greater flexibility in the safe development of innovative therapies; streamline processes toward greater efficiency and clarity; and align with international best practices regarding oversight and public access to information.

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

Health Canada continues to engage a range of stakeholders to validate and inform early policy thinking.

During the COVID-19 pandemic, Health Canada further engaged stakeholders in introducing temporary regulations to expand access to clinical trials for COVID-19. The Interim Order Respecting Clinical Trials for Medical Devices and Drugs relating to COVID-19 has similar agile approaches to those in this proposal. Stakeholder feedback on these temporary regulations will also help inform the policy approach.

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.

Date of last review or amendment

Natural Health Products Regulations: 2018

Medical Devices Regulations: 2019

Food and Drug Regulations: 2019

Targeted start for review

2022

Stakeholder Feedback

Prior to consultation on the broader regulatory proposal for all business lines, as described above, Health Canada undertook a targeted consultation with key stakeholders on potential regulatory improvements for investigational testing authorities (for medical devices). The consultation period closed in fall 2019.

In addition, Health Canada released a discussion paper: "Agile regulations for advanced therapeutic products and clinical trials" in July 2019. The consultation period closed in September 2019.

For further information

Related information on clinical trials for drugs can be found on Health Canada's website, including a June 2019 Notice to Stakeholders on an interpretive guidance on the Investigational Use of Marketed Drugs in Clinical Trials.

Related information on investigational testing of medical devices can be found on Health Canada's website.

Related information on clinical trials for natural health products can be found on Health Canada's website.

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: hc.lrm-mlr.sc@canada.ca

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)

Enabling Act

Food and Drugs Act

Rationale

Health Canada is proposing to amend the Food and Drug Regulations to implement an agile, modern licensing scheme for prescription drugs and over-the-counter drugs (OTCs). These regulatory changes will improve and maintain safety while helping to support economic growth.

The initiative intends to address stakeholder comments received under targeted review and modernization consultations that the current licensing system for most health products is too rigid and hard to understand.

Narrative

The proposed amendments to the Food and Drug Regulations would address issues by using modern, clear language to improve and maintain safety by:

  • Introducing regulatory tools to manage on-market risks and uncertainties (e.g., terms and conditions, risk management plans, etc.);
  • Introducing more targeted enforcement powers (e.g., suspension and revocation); and,
  • Creating formal transparency requirements to disclose information about the risks, benefits and uncertainties of drugs.

Support for economic growth will be achieved by:

  • Removing outdated requirements; creating technology-neutral regulations (e.g., references to faxes);
  • Increasing harmonization and alignment with international regulators; and,
  • Enabling a lower-cost market authorization pathway for lower-risk drugs.

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

The Department intends to engage key stakeholders throughout 2021 as it develops this proposal.

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.

Note: These amendments were previously a component of 'Regulations amending the Food and Drug Regulations - Part C, and the Medical Devices Regulations (Flexible Lifecycle-based Licensing for Drugs and Medical Devices) but has now been separated into its own initiative.

Date of last review or amendment

Food and Drug Regulations: 2019

Targeted start for review

Food and Drug Regulations: 2022

For further information

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: hc.lrm-mlr.sc@canada.ca

Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition) and Order Amending Schedule 2 of the Hazardous Products Act.

Enabling Act

Hazardous Products Act

Rationale

Health Canada is proposing to amend 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 regulations to amend 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.

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

The publication of the amendments to the regulations in the Canada Gazette, Part ll is expected to take place in winter-spring 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

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: hc.whmis-simdut.sc@canada.ca

Pest Control Products Regulations

Enabling Act

Pest Control Products Act

Rationale

To undertake the first comprehensive review of the Pest Control Products Regulations since its coming into force.

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, sodium bromide and potassium monopersulfate, 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.
  • 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 in order to build a stronger and sustainable pesticide regulatory program that strengthens health and environmental protection and leads to improved timeliness of scientific decisions.

Narrative

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

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.

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 (Labelling): SOR/2019-133").

Targeted start for review

The review of the Pest Control Products Regulations started in 2016, and is ongoing. Input was also received via the 2018 Targeted Regulatory Review: Agri-food and Aquaculture Roadmap.

Stakeholder Feedback

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, in 2017, via its "Proposed Re-evaluation Decision "PRVD2017-10, Sodium Bromide" and in 2018, via its regulatory proposal document "PRO2018-03 Consultation on Proposed Amendments to the Pest Control Products Regulations (Product Exemptions)". 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. 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: 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.

Project to modernize the post-market review process for pest control products; The Pest Control Products Act and regulations were reviewed and confirmed to be sufficient at this time. Thus, no Act or regulatory changes are required at this time. Modernization will be implemented through changes to applicable policies.

For further information

For further information, please consult:

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: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

Proposed New Reviews

Regulations Amending the Carriages and Strollers Regulations

Enabling Act

Canada Consumer Product Safety Act

Rationale

Health Canada is proposing to amend 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 consumer's 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 regulations contain performance requirements and test methods that may not address the hazards related to designs developed after 1985.

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.

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:

Nicholas Shipley
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: hc.cps-spc.sc@canada.ca

Regulations Amending Certain Regulations Made Under the Canada Consumer Product Safety Act (Surface Coating Materials)

Enabling Act

Canada Consumer Product Safety Act

Rationale

Health Canada is proposing to amend 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 to amend 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.

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 2021 and last 70 days.

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

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact:

Nicholas Shipley
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: hc.cps-spc.sc@canada.ca

Regulations Amending the Tents Regulations, the Toys Regulations and the Textile Flammability Regulations

Enabling Act

Canada Consumer Product Safety Act

Rationale

Health Canada is proposing to amend 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 that cannot also function as outdoor shelters.

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

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.

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 30 days.

Date of last review or amendment

An internal review of the regulations was completed in 2015.

Targeted start for review

2019

For further information

Additional information can be requested from the departmental contact.

Departmental or agency contact:

Nicholas Shipley
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: hc.cps-spc.sc@canada.ca

Regulations Amending the Radiation Emitting Devices Regulations pertaining to Laser Devices

Enabling Act

Radiation Emitting Devices Act

Rationale

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

Narrative

Health Canada is proposing to amend 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.

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.

Health Canada intends to undertake an online public consultation process on this proposal by June 2021.

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 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) in order to correct a negative sign to a positive sign. Part VIII was last amended in 1981.

Targeted start for review

2020

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: hc.erhsdgeneral-dssergenerale.sc@canada.ca

Departmental Contact Information

For general inquiries on the stock review plan, contact Health Canada's Departmental Regulatory Affairs Section at hc.dra-arm.sc@canada.ca.

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