New terms and conditions for human and veterinary drugs: Notice

December 20, 2024

New agile amendments introduced

There are new targeted provisions and regulatory amendments for the Food and Drug Regulations (FDR) and Medical Devices Regulations (MDR). These amendments were introduced through the agile regulatory package and are part of Health Canada's modernization work.

The amendments will:

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 will be added to the FDR on April 1, 2027:

a new broad terms and conditions (T&Cs) authority for 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 disease
- Division 8, section C.08.003.2

Learn more about the amendments:

Canada Gazette, Part II

Consultation on proposed amendments

We consulted a wide range of stakeholders, including the public, about the proposed amendments in December 2022 as part of the agile regulatory package.

The amendments were outlined in the Draft guidance on terms and conditions (T&Cs) for human and veterinary drugs. This draft guidance gave information on the: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 said the T&Cs process and the notice of compliance with conditions (NOC/c) for human drugs and its relation to T&Cs should be made clearer.

We are revising the draft guidance to reflect the comments we received. We will then hold a second round of public consultation in spring 2025.

Learn more about the agile regulatory package:

Canada Gazette, Part I

When the new T&C 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 receive a DIN, for both human and veterinary drugs.

The new authority will replace the:

NOC/c policy for human drugs
T&C provisions that are specific to opioids and public health emergency drugs (for example, COVID-19 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 before April 1, 2027, will continue to fulfill their commitments under the NOC/c guidance.

New draft guidance documents

We will be publishing 2 guidance documents for a 60-day public consultation period in spring 2025:

Draft Guidance on Terms and Conditions (T&Cs) for Human and Veterinary Drugs
- This revised version was consulted on in December 2022.
Draft Guidance on Notice of Compliance with Terms and Conditions (Promising Evidence) for Human and Veterinary Drug Submissions
- This guidance will focus on filing a new drug submission or supplement to a new drug submission for authorization to sell a human or veterinary drug where the information supporting the drug submission is based on promising evidence of efficacy.

We will notify stakeholders either through the Really Simple Syndication (RSS) feed or by email when the 2 draft guidance documents are posted for consultation.

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.

Page details

2024-12-20

Choose a theme