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

Current status: Open

Opened on December 17, 2022, and will close to new input on March 27, 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:

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:

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:

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:

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Notice: Consultation on draft guidance on management of rolling reviews for drug submissions New Human and veterinary drugs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Notice: Consultation on draft Guidance on the collection and analysis of disaggregated data in clinical trials New Human drugs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

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