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.
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 decision 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- removing outdated requirements, including requirements for specific technology needs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:
Industry will see:
- modern, clarified regulations
- lower costs for low-risk drugs
- earlier market access for innovative, promising drugs with proven safety and efficacy
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
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.
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
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