Synopsis of Draft Guidance on Health Canada’s T&Cs

During a presentation at DIA (Drug Information Association) Canada 2025, held in Gatineau, Quebec, in late October, Kristen Zorn, Manager of Policy Development at Health Canada, presented the Terms and Conditions (T&Cs) objectives for drug products. The T&Cs fall under Health Canada’s Agile Licensing amendments, also referred to as Agile Regulations, which were published in December 2024i, revamping regulations that require modernisation.

Health Canada is strengthening its ability to enforce post-market requirements with the introduction of the new regulations on T&Cs. These T&Cs are broad and flexible tools that can be used to manage uncertainty and protect patients, while permitting market access. They will apply to both new drug product authorisations and existing approved drugs, requiring sponsors to continue generating and submitting sufficient evidence following a drug’s approval. As part of the T&Cs, the current Notice of Compliance with Conditions (NOC/c) policy is expected to be replaced by the T&C framework when it comes into effect on April 1, 2027.

This side-by-side comparison seeks to explain, at a practical level, what Health Canada’s T&Cs versus NOC/c are, when they’re used, what they typically require, what is the scope and implications.

	NOC/c (Notice of Compliance with Conditions)	Terms and Conditions (T&Cs)
1) What they are	A conditional approval mechanism for certain drugs (serious, life-threatening, or severely debilitating diseases) where evidence is promising but not yet fully confirmed. NOC/c is a registration pathway.	Legally/administratively enforceable obligations attached to an authorisation (e.g., studies, safety reporting, labelling, risk minimisation measures). T&Cs are a broader tool, not a standalone registration pathway.
2) When they are used	Used at the time of initial market authorisation when confirmatory evidence is still pending but early data support access.	Used when Health Canada wants to require specific post-market actions to manage uncertainty or emerging risks. They can be attached at authorisation or post-market (including after a product is already marketed).
3) Scope and flexibility	Generally focused on a defined set of conditions tied to converting the authorisation to a “full” NOC (e.g., confirmatory trials, timelines, specific undertakings).	Broader and more flexible that can cover: Confirmatory trials / additional studies (including real-world evidence) Enhanced pharmacovigilance and extra reporting Labelling/packaging updates Risk minimisation measures and distribution controls Collect information to continuously assess benefits and risks Manage significant uncertainties related to a drug’s safety, efficacy or quality T&Cs can also be amended/added as new information arises.
4) Regulatory and operational implications	Sponsors shall receive qualifying notice (QN) at the end of submission review. Review clock stops upon issuance of qualifying notice (QN). Expectations on completing confirmatory work within agreed upon time frame to maintain authorisation. Full approval is contingent upon completion of confirmatory commitments.	Sponsors shall receive anticipatory T&C letter at the end of submission review. The review clock does not stop upon issuance of anticipatory T&C letter. Power of enforcement for T&Cs are within the regulations. Can create ongoing operational obligations even for fully approved products.

Process Comparison for Authorisation of New Drugs and Supplemental
New Drugs (with Promising Evidence) Under NOC/c and T&Cs

	Current Notice of Compliance with Conditions (NOC/cs)	Proposed Promising Evidence (PE) with T&Cs
Finalizing Conditions	Qualifying Notice (QN) issued (stops the clock)	Anticipatory T&C letter issued (does not stop the clock)
	Target 30 days to respond, 30 days to review	If expedited review timelines (priority review/AC-PE) 60 days added to target. If 300-day target, no change.
	Sponsor agrees to NOC/c and proposes commitment details	Sponsor makes representations (e.g., feasibility, less burdensome means)
	Sponsor signs Letter of Undertaking, included with the NOC	HC imposes T&C(s) on the DIN(s), T&C Letter issued with the NOC
Transparency	QN posted to HC website, InfoWatch posting	Information about imposed T&Cs posted to HC website, InfoWatch posting for confirmatory T&Cs

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

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/new-draft-guidance-documents-terms-conditions-human-veterinary-drugs-submissions-promising-evidence-clinical-efficacy.html

About the author:

Mỹ Dang is Director, Regulatory Affairs, at Innomar. She has over 20 years of experience in regulatory affairs within the pharmaceutical industry, specializing in drugs and biologics across various therapeutic areas. Mỹ has expertise in regulatory strategy, submission management, quality assurance, as well as pharmacovigilance and medical information. Currently, she serves on the Board of Directors for CAPRA and BioCanRx and contributes to DIA Canada’s Program Committee.

This blog is intended to communicate Innomar Strategies’ capabilities which are backed by the author’s expertise. However, Innomar Strategies and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice.