As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations (FDRs). The amendments included authorities that will come into force on April 1, 2027, permitting Health Canada to (i) impose terms and conditions (T&Cs) on all drugs with a drug identification number (DIN) and (ii) consider whether T&Cs could address promising evidence on the effectiveness of a new drug intended for serious or severely debilitating diseases or conditions.
On December 12, 2025, Health Canada launched a consultation on two draft guidance documents relating to these new T&C authorities:
- Draft guidance on terms and conditions for human and veterinary drugs: This document provides guidance to manufacturers and Health Canada staff on the use of T&Cs in accordance with Part C, Division 1, section C.01.014.21 of the FDRs. While a draft guidance was first published in December 2022, Health Canada notes that the current draft has been substantially revised. (Consultation page)
- Draft guidance on human and veterinary drug submissions based on promising evidence and terms and conditions: This guidance focuses on new drug submissions based on promising evidence of clinical efficacy where T&Cs are considered pursuant to section C.08.003.2 of the FDRs. (Consultation page)
Once the new authority to impose T&Cs takes effect on April 1, 2027, it will replace the following policies provisions and guidance:
The consultation is open until February 10, 2026.
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