In December 2025, Health Canada published new draft guidance documents detailing when and how terms and conditions (T&Cs) may be imposed on drugs pursuant to amendments to the Food and Drug Regulations (FDR). The related FDR amendments will take effect on April 1, 2027. T&Cs can potentially apply to any drug with a drug identification number (DIN) at any point in its lifecycle. In particular, T&Cs can be used to approve promising new drugs for serious diseases that are currently approved under the Notice of Compliance with Conditions policy (NOC/c). The current draft T&C guidance “substantially revised” and replaces a previous draft T&C guidance published in 2022. Health Canada is accepting feedback on the new draft T&C guidance documents until February 10, 2026.
Agile drug licensing: Health Canada consulting on new “terms and conditions” guidance to replace its Notice of Compliance with Conditions policy
