Regulatory innovation for health products: Agile licensing for drugs

On this page

• Why we are updating our drugs regulations
• Our plan
• Implications from COVID-19
• Opportunities for comment
• Contact us

Why we are updating our drugs regulations

Canadians rely on Health Canada to ensure they have access to safe and effective drugs of high quality. All drugs authorized for sale in Canada are thoroughly reviewed and monitored for safety. However, the drug regulations we use were developed when a common set of rules worked well for most products.

The market has evolved to include more complex and personalized therapies. Our regulatory system also needs to evolve, to ensure Canadians have access to the drugs they need.

Our plan

We are creating new, more agile regulations to better support drug oversight, both before and after sale. These updated regulations will improve safety by:

• introducing regulatory tools, such as terms and conditions, to manage risks and uncertainties once the product is for sale
• creating transparency requirements around the risks, benefits and uncertainties of drugs
• introducing more targeted enforcement powers, such as suspending and revoking authorizations

The updated regulations will support economic growth by:

• aligning with international regulators
• allowing reviews of certain drugs that address unmet medical needs to rely on the authorization of a trusted foreign regulator
• removing outdated requirements, including requirements for specific technology needs

The new regulations will benefit both Canadians and industry.

Patients and animal owners will see:

• improved access to innovative products
• increased transparency about the risks, benefits and uncertainties associated with individual drugs

Health care providers will be:

• able to prescribe more products
• more confident that they're well informed about risks, benefits and uncertainties

Provinces and territories will be able to support their funding decisions with up-to-date evidence about an authorized drug's:

• risks
• benefits
• uncertainties

Industry will see:

• updated regulations
• fees based on level of effort for licensing low-risk, non-prescription self-care drugs
• earlier market access for innovative, promising drugs with proven safety and efficacy

To ensure a successful transition, we will be introducing the updated regulations in phases. We will engage with Canadians and our health system partners throughout this process.

Implications from COVID-19

The COVID-19 pandemic created an unprecedented demand for health products to help manage and prevent the virus. As part of the government's broad response to the pandemic, Health Canada introduced temporary measures to expedite the regulatory review of COVID-19 health products.

This included the interim order for drugs and vaccines, which provided more agility to expedite the approval of COVID-19-related drugs and vaccines. The order included some of the elements planned for the agile licensing initiative, such as the ability to:

• apply terms and conditions on approvals
• leverage the use of rolling reviews for drug and vaccine submissions

The interim order was in effect until September 16, 2021. We introduced transition measures to ensure that COVID-19-related drugs authorized under the interim order could continue to be imported and sold in Canada. These measures were published in Canada Gazette, Part II.

COVID-19 reinforced the need for regulatory agility to support timely access to needed health products without compromising safety, quality or efficacy. Our experience responding to the pandemic will inform our work moving forward.

Opportunities for comment

Health Canada notified stakeholders on our intent to amend the Food and Drug Regulations and Medical Devices Regulations to enhance our regulatory agility. We published our intent in a notice in Canada Gazette, Part I in 2021.

Building on the feedback received, we consulted on proposed amendments to these sets of regulations.

This consultation was open from December 17, 2022, to April 26, 2023. The consultation included proposed regulations as well as a number of new and updated guidance documents and notices for comment.

Contact us

Ed Morgan
Director General
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: hpfb.engagement-mobilisation.dgpsa@hc-sc.gc.ca