Consultation on proposed agile regulations and guidance for licensing drugs and medical devices

Current status: Closed

Opened on December 17, 2022, and closed to new input on April 26, 2023, at 11:59 pm Eastern Standard Time (EST).

Health Canada is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to advance our modernization agenda and help to reduce regulatory irritants and roadblocks to innovation. We are seeking feedback on both the proposed regulations and on multiple guidance documents related to the proposal.

This regulatory initiative is part of our regulatory innovation agenda and will contribute to the government’s biomanufacturing and life sciences strategy.

Join in: How to participate

Share your ideas online

To provide feedback on the proposed regulations, submit your comments through Canada Gazette, Part I.

and

To submit comments on the multiple guidance documents and notices listed below related to this proposal, please use this online stakeholder feedback form:

• PDF fillable/saveable version - 163 KB
• Microsoft Word version - 126 KB

Participate by mail

Send a letter with your ideas and input to the address in contact information below.

Who is the focus of this consultation

We are seeking comments from:

• academics
• consumer and patient safety organizations
• drug and medical device industry
• health system partners
• general public

Key items for comment

Health Canada is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations as part of our modernization work. The amendments will also:

• reduce regulatory issues and roadblocks to innovation
• make Canada’s science-based regulatory system more agile and internationally aligned

The proposal also takes into account recent experience with regulatory agilities successfully piloted as part of our response to the COVID-19 pandemic.

We are seeking your ideas and input on the following topics:

• using terms and conditions on drug approvals and broadening their scope for Class II, III and IV medical devices
• allowing rolling reviews of certain drug submissions, including drugs that address a public health emergency
• requiring risk management plans for higher-risk human drugs
• updating the requirements for certain drugs that claim a manufacturer’s standard
• repealing requirements for labelling of the standard for specific drugs
• repealing outdated requirements and replacing them with those that reflect current practices
• clarifying the authority to consider information obtained outside of a new drug submission to support Health Canada’s examination of that submission for a new drug
• requiring manufacturers to submit disaggregated data for new and supplemental human drug submissions

The following guidance documents and notices are related to this proposal.

Name of guidance or notice	New guidance or update to existing guidance	Subject of guidance (human drugs, veterinary drugs or medical devices)
Notice: Guidance on terms and conditions for human and veterinary drugs	New	Human and veterinary drugs
Guidance on terms and conditions (T&Cs) for human and veterinary drugs	New	Human and veterinary drugs
Notice: Consultation on draft guidance on management of rolling reviews for drug submissions	New	Human and veterinary drugs
Guidance on management of rolling reviews for drug submissions	New	Human and veterinary drugs
Notice: Consultation on draft Guidance on the collection and analysis of disaggregated data in clinical trials	New	Human drugs
Guidance on the collection and analysis of disaggregated data in clinical trials	New	Human drugs
Notice: Biologic drugs (Schedule D drugs) – Division 4 proposed regulatory amendments	New	Human drugs
Notice: Guidance on the Food and Drug Regulations for public health emergency drugs	New	Human and veterinary drugs
Guidance on the Food and Drug Regulations for public health emergency drugs	New	Human and veterinary drugs
List of Influenza Vaccines for Which Supplements to New Drug Submissions Can Be Filed	New	Human drugs
List of Conditions that Threaten Public Health in Canada	New	Human drugs
Regulatory cooperation - Canadian guidance on veterinary drug simultaneous reviews with the United States	New	Veterinary drugs
Guidance: Labelling of pharmaceutical drugs for human use	Update	Human drugs
Quality (chemistry and manufacturing) Guidance: New Drug Submissions and Abbreviated New Drug Submissions	Update	Human drugs
Notice: Changes to guidance on submitting risk management plans	New	Human drugs
Guidance: Submitting risk management plans	Update	Human drugs
Guidance: Terms and conditions for medical devices	New	Medical devices

Contact us

Bruno Rodrigue, Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Ave
Ottawa ON K1A 0K9

Email: hpfb.engagement-mobilisation.dgpsa@hc-sc.gc.ca