Regulatory innovation for health products: Agile licensing for drugs

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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:

The new regulations will support economic growth by:

The new regulations will benefit both Canadians and industry.

Patients and animal owners will see:

Health care providers will be:

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

Industry will see:

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:

We will learn from this experience to inform the development of our regulatory proposal.

Upcoming opportunities for comment

We will engage with stakeholders in 2021 to seek feedback on proposed regulatory changes. We'll make further details available once plans are finalized.

Stakeholders can comment on the regulatory proposal for the Food and Drug Regulations during the Canada Gazette, Part I, public comment period.  Timelines can be found on Health Canada's Forward Regulatory Plan.

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

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