Health Canada’s Regulatory Stock Review Plan: 2019 – 2022

The Regulatory Stock Review Plan is a public list and description of planned reviews of regulations that Health Canada plans to undertake within a three-year period. It is intended to give Canadians, including businesses and Indigenous peoples, and trading partners, an 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.

The department consulted with stakeholders and its planned initiatives to address the issues, irritants, and bottlenecks identified by stakeholders are 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 stock review plan.

Each initiative associated with the stock review plan identifies a Health Canada contact point for the planned reviews. The stock review plan will be adjusted and updated over time to reflect Health Canada’s regulatory priorities and changes to the operating environment.

Existing legislation and related regulations remain in force.

Health and Biosciences Sector Regulatory Review Roadmap

The Health and Biosciences Sector Regulatory Review Roadmap outlines Health Canada's plan to address the issues, irritants, and bottlenecks identified by stakeholders that affect innovation and economic growth in the health and biosciences sector. The Roadmap identifies a suite of initiatives and proposed timelines to advance regulatory modernization. Health Canada grouped the issues under the following themes, based on input from stakeholders:

Theme 1: Integration

This theme focuses on the development of integrated regulatory frameworks to improve consistency and predictability across increasingly overlapping product categories.

Refer to the following Health Canada Forward Regulatory Plan proposals for more information on proposed regulatory changes related to this theme:

Theme 2: Global Systems

This theme focuses on global approaches to improve efficiency and reduce regulatory burden by leveraging partnerships with international regulators. The increasingly global nature of the health and biosciences sector requires that the department align itself with international regulatory partners, as appropriate.

Refer to the following Health Canada Forward Regulatory Plan proposals for more information on proposed regulatory changes related to this theme:

Theme 3: Risk-based Approaches

This theme focuses on adopting a more risk-based approach to reduce burden and effectively deploy resources, such as shifting from one-size-fits-all approaches to applying a level of regulatory oversight that is flexible and proportionate to risk.
Refer to the following Health Canada Forward Regulatory Plan proposals for more information on proposed regulatory changes related to this theme:

Theme 4: Agile Frameworks

This theme focuses on agile frameworks, which, while protecting the health and safety of Canadians, are responsive to the health care sector and emerging science and technology. Agile regulatory frameworks are expected to enable a more flexible pathway for getting new and innovative products to market, while enabling more flexible, risk-based oversight of these products.

Health Canada’s agile frameworks are developed in collaboration with stakeholders to ensure that they support the safety of workers, and support and enable emerging and innovative heath care practices and processes. Refer to the following Health Canada Forward Regulatory Plan proposals, for more information on proposed regulatory changes related to this theme:

Health Canada’s Novel Approaches

Health Canada also identified an additional regulatory proposal through the targeted sectoral review that will use new, more collaborative and flexible approaches to regulation. Health Canada is proposing to reduce re-testing requirements for certain lower risk imported products from countries having a comparable good manufacturing practices compliance program. Refer to the following Health Canada Forward Regulatory Plan proposal, for more information on the proposed regulatory change:

Agri-food and Aquaculture Regulatory Review Roadmap

The Agri-food and Aquaculture Regulatory Review Roadmap lays out a regulatory modernization plan in support of innovation and economic growth in the agri-food and aquaculture sector. Health Canada identified a number of initiatives and proposed timelines to advance regulatory modernization in this sector under the following themes:

Theme 1: Clear, Agile, Responsive Regulations

This theme supports the desire for regulations that are clear so that they are easily understood, flexible so that they continue to be appropriate as the environment evolves, and responsive so that they can accommodate changes in the Canadian and global business environment.

Refer to the Roadmap or the following links/Health Canada Forward Regulatory Plan proposals, for more information on action/proposed regulatory changes related to this theme:

Theme 2: Competitiveness in Domestic and International Markets

This theme focuses on key areas of improvement in support of Canadian competitiveness and trade interests, both domestically and abroad. It also addresses opportunities for better alignment and reducing duplication in oversight across jurisdictions, contributing to reduced regulatory burden for businesses.
Refer to the following Health Canada Forward Regulatory Plan proposal for more information on proposed regulatory changes related to this theme:

Theme 3: Risk-based, efficient, predictable regulatory programs

This theme focuses on regulatory programs and services. It addresses concerns raised that programs supporting the agri-food and aquaculture sector are not timely, predictable, sufficiently risk-based, or have not adopted efficient processes such as electronic submission platforms.

Refer to the Roadmap or the following Health Canada Forward Regulatory Plan proposal for more information on proposed action/regulatory changes related to this theme:

Additional Legislative and Regulatory Reviews

Health Canada administers several statutes that require periodic reviews. In addition to the regulatory stock review plan initiatives outlined above, the following statutes and regulations will be reviewed within the 2019-2022 review period:

Cannabis Act

The Cannabis Act and supporting regulations, including the Cannabis Regulations and Industrial Hemp Regulations, came into force on October 17, 2018. The Act and its regulations create a legal framework for controlling the production, distribution, sale, and possession of cannabis across Canada. Health Canada administers this legislation on behalf of the Minister of Border Security and Organized Crime Reduction (see Order in Council PC 2018-1418).

Timeline for review

As outlined in section 151.1 of the Cannabis Act, the Minister must initiate a review of the Act and its administration and operation three years following the coming into force of the Act (i.e., by October 17, 2021). This review will examine the impact on public health and, in particular, on the health and consumption habits of young persons in respect of cannabis use, the impact of cannabis on Indigenous persons and communities, and the impact of the cultivation of cannabis plants in a dwelling-house. A report outlining the results of the review, including any findings or recommendations, must be tabled in Parliament within 18 months of the initiation of the review (i.e., no later than April 17, 2023).

Departmental contact information

Controlled Substances and Cannabis Branch
Health Canada
Email: cannabis@canada.ca

Pest Control Products Act and Pest Control Products Regulations

The Pest Control Products Act (PCPA) and the associated Regulations apply to all products manufactured, possessed, handled, stored, transported, imported, distributed or used in Canada to control pests. Pest control products include a variety of products such as insecticides, herbicides and fungicides for use in agriculture, forestry, industry and households. This Act and the Regulations protect human health and the environment through a pre- and post-market evaluation program to prevent unacceptable risks. Health Canada's Pest Management Regulatory Agency (PMRA) administers this legislation.

Timeline for review

In accordance with subsection 80.1(1) of the PCPA, the Act stands referred to a committee of Parliament for review every seven years. The Act will next stand referred for review in 2020. The review committee shall within one year after the review is undertaken or within such further time as Parliament may authorize submit a report that includes any recommended changes to the PCPA or its administration.

The PMRA is also conducting a comprehensive review of the Pest Control Products Regulations (PCPR). It is the first such review since the regulations were established in 2006. The review is aimed at ensuring the PCPR continues to meet program objectives (for example, of health and environmental protection) in an effective and efficient manner, while attempting to minimize regulatory burden on regulated parties.

Departmental contact information

Pest Management Regulatory Agency
Health Canada
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

Tobacco and Vaping Products Act

The Tobacco and Vaping Products Act (TVPA) became law on May 23, 2018, replacing the Tobacco Act.  The TVPA regulates the manufacture, sale, labelling and promotion of tobacco products and vaping products.  Health Canada administers this legislation.

Timeline for review

In accordance with subsection 60.1(1) of the Tobacco and Vaping Products Act, the Minister must initiate a review of the provisions and operation of the Act three years following coming into force of the Act (i.e., by May 23, 2021). Once initiated, the Minister will have one year to table the final report in each House of Parliament (i.e., no later than May 23, 2022).

Departmental contact information

Tobacco Control Directorate
Controlled Substances and Cannabis Branch
Health Canada
Email: hc.tcp.questions-plt.sc@canada.ca

Hazardous Products Regulations

In addition to the amendments that will be made to the Hazardous Products Regulations to align with the recent legislative changes of Hazardous Materials Information Review Act, updates will be sought separately to the Hazardous Products Regulations to align more closely with the seventh revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Departmental contact information

Workplace Hazardous Materials Bureau
Consumer and Hazardous Products Safety Directorate
Health Canada
Email: hc.whmis-simdut.sc@canada.ca

Regulations Made Under the Canadian Environmental Protection Act

Health Canada co-administers certain aspects of the Canadian Environmental Protection Act, 1999 (CEPA) with Environment and Climate Change Canada (i.e., controlling toxic substances). Refer to the following plan for more information on a number of regulations made under CEPA, identified for review:

Departmental Contact Information

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

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