Health Canada updates guidance on management of drug submissions and applications: Notice

October 1, 2025

Health Canada has updated the 2022 version of the Guidance on management of drug submissions and applications. The changes to the guidance take effect immediately and will ensure that information for drug submissions and applications is applied consistently.

We have reformatted the guidance to make it clearer and easier for stakeholders to use. We have also made minor updates, such as:

• adding public health emergency drugs, introduced through the Agile regulatory package
• removing cost recovery hold
• clarifying descriptions of existing procedures and
• updating contact information and definitions

We are planning to make more significant updates in the future and will consult with stakeholders at that time.

Contact us

If you have any questions, contact:

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
E-mail: policy_bureau_enquiries@hc-sc.gc.ca