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
• Upcoming 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 well-reviewed and monitored for safety. However, the drug regulations we use were developed when a common set of rules worked well for most products. This approach is no longer the best way to meet today's needs.

The Canadian market now includes a much larger number of drugs that reflect a wider range of risks. Our drug regulatory system needs to be more agile to give people better access to the drugs they need. 

Our plan

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

• creating transparency requirements around the risks, benefits and uncertainties of drugs
• introducing more targeted enforcement powers (like suspension and revocation of authorizations)
• introducing regulatory tools to manage risks and uncertainties once the product is for sale (like terms and conditions)

The new regulations will support economic growth by:

• aligning with international regulators
• allowing the use of decisions made by trusted foreign regulators in certain circumstances
• removing outdated requirements, including requirements for specific technology needs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 continuous, 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

It will take significant effort and time to make these changes. To ensure a successful transition, we will be introducing the new regulations in phases. We will engage with Canadians and our health system partners throughout this process.

Implications from COVID-19

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

• apply terms and conditions on approvals
• use the decision of a trusted foreign regulatory authority in certain circumstances

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

We are using our experience with COVID-19 to help us develop our regulatory proposal.

Upcoming opportunities for comment

For the first phase of the Agile Licensing for Drugs proposal, Health Canada is launching a consultation on the proposed targeted amendments to the Food and Drug Regulations and Medical Devices Regulations.

To find out more, please see the Canada Gazette, Part I publication.

Stakeholders can comment on this regulatory proposal until October 28, 2021.

Contact us

Ed Morgan
Director General
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
E-mail: hc.ppiad-dppai.sc@canada.ca