New draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy: Notice

December 12, 2025

New agile amendments - terms and conditions

In December 2024, Health Canada published amendments to the Food and Drug Regulations (FDR) in Canada Gazette, Part II, entitled "Regulations amending certain regulations made under the Food and Drugs Act (Agile Licensing)". As part of Health Canada's modernization work, these amendments aim to:

reduce regulatory issues and roadblocks to innovation
make Canada's science-based regulatory system more agile
bring our regulatory system in line with international approaches

Among the amendments, the following authorities under the FDR will come into effect on April 1, 2027:

a new broad terms and conditions (T&Cs) authority applicable to all drugs with a drug identification number (DIN)
- Part C, Division 1, section C.01.014.21
a new authority to allow Health Canada to consider whether T&Cs could address promising evidence on the effectiveness of a new drug intended for serious or severely debilitating diseases or conditions
- Division 8, section C.08.003.2

Learn more about the amendments:

Canada Gazette, Part 2, Volume 158, Number 26: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)

Consultation on draft guidance on terms and conditions for human and veterinary drugs

Prior to publication in Canada Gazette Part II, the Agile Licensing Regulations were consulted on in 2022. At that time, we also consulted a wide range of stakeholders, including the public, on an initial first draft of the Draft guidance on terms and conditions (T&Cs) for human and veterinary drugs to accompany the T&Cs proposed regulations. This draft guidance gave information on the:

proposed regulatory authority for T&Cs as set out in Part C, Division 1, section C.01.014.21 of the FDR
purpose of T&Cs and operational processes to be followed when applying T&Cs
process to be followed when fulfilling T&Cs

In general, stakeholders supported the T&Cs authority and its intended use. However, stakeholders indicated that the notice of compliance with conditions (NOC/c) process for human drugs and its relation to the new T&Cs process should be made clearer.

To address comments received, the draft T&Cs guidance was substantially revised. In addition, a second Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions was developed, to provide clarity on how the T&Cs authority will replace the current notice of compliance with conditions (NOC/c) for human drugs policy. This second draft guidance will replace the NOC/c guidance when the T&Cs authority come into effect.

Learn more:

Initial first draft: Draft guidance on terms and conditions (T&Cs) for human and veterinary drugs
T&Cs proposed regulations

When the new terms and conditions authority comes into force

The new, broad authority for T&Cs will take effect on April 1, 2027. It will apply to all drugs that are assigned a DIN, for both human and veterinary drugs.

The new authority will replace the:

Guidance Document: Notice of Compliance with Conditions (NOC/c) for human drugs
T&C provisions in the FDR that are specific to opioids (subsection C.01.014.21(1)) and public health emergency drugs (subsection C.01.014.21(1.1))
Policy on terms and conditions for veterinary drugs

T&Cs imposed on opioids and public health emergency drugs before April 1, 2027, will remain in effect.

Amendments to existing T&Cs after this date will be completed in accordance with the new authority. This will apply to any existing conditions imposed on opioids and public health emergency drugs.

Manufacturers that were issued a notice of compliance with conditions for human drugs before April 1, 2027, will continue to fulfill their commitments under the NOC/c guidance document even after the broad authority for T&Cs takes effect on April 1, 2027. However, it should be noted that T&Cs can be imposed at any time once a drug has been issued a DIN.

Seeking your feedback on new draft guidance documents

Health Canada has experience in imposing and amending T&Cs on opioids and COVID-19 drugs. We have used this knowledge to develop these new draft guidance documents. In addition, the NOC/c guidance document informed the proposed process for implementing the T&Cs regulatory requirements for drugs.

We are consulting stakeholders for 60 days seeking your comments on the following two draft guidance documents that are to be read in conjunction with the agile regulations:

Draft guidance on terms and conditions for human and veterinary drugs (first draft was consulted on at the time of Canada Gazette I pre-publication of agile regulations)
- This draft version has been revised substantially from the version that was consulted on in December 2022.
Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions
- This draft guidance document will replace the NOC/c guidance document and the Policy on terms and conditions for veterinary drugs once the T&Cs authority come into effect. It should be read in conjunction with the Draft guidance on terms and conditions for human and veterinary drugs.
- This draft guidance focuses on filing a new drug submission or supplement to a new drug submission for a manufacturer seeking authorization to sell a human or veterinary drug where the information supporting the drug submission is based on promising evidence of clinical efficacy.

Contact us

If you have any questions or comments about this notice, email the Bureau of Policy, Science and International Programs, Pharmaceutical Drugs Directorate, at policy_bureau_enquiries@hc-sc.gc.ca.

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2025-12-12