Forward Regulatory Plan 2022-2024: Regulations amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs)

Title of Regulatory Initiative

Regulations amending the Food and Drug Regulations (Agile Regulations for Licensing Drugs)

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing amendments to the Food and Drug Regulations to enable the implementation of 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.

This regulatory initiative is associated with Health Canada's Stock Review Plan.

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: Regulations Amending the Food and Drug Regulations (Use of Foreign Decisions Pathway); Regulations Amending the Natural Health Products Regulations and the Food and Drug Regulations (Self-Care Framework); Regulations Amending the Medical Devices Regulations (Agile Regulations for Licensing Medical Devices).

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

Regulatory cooperation efforts (domestic and international)

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

This regulatory proposal would better align Health Canada requirements with those of other jurisdictions such as the United States and European Union.

Potential impacts on Canadians, including businesses

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.

Consultations

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

Stakeholder engagement and consultation on aspects of this initiative took place in 2020 and 2021 in the context of the Interim Orders related to COVID-19, the associated transition regulations that have certain components with similar regulatory approaches to those in 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 fall 2022.

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

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 contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-321-4235
Email: lrm.consultations-mlr@hc-sc.gc.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

June 2019

Consult Health Canada’s acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada’s implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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