New Regulatory Tools: Monograph Combination Guide & List of Interchangeable Terms

Posted Date: 2-December-2025

Updated Guidance for Industry on Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products, effective October 1, 2026

 

After several months of consultation and involvement with your Product Compliance and Market Access Committee, we are pleased the Natural and Non-prescription Health Products Directorate (NNHPD) has published two new regulatory tools to advance its commitment to improve processes through clearer submission pathways and more flexible labelling options:

 

  • a Monograph combination guide; and
  • a List of interchangeable terms (for labelling of NHPs and NPDs).

 

The creation of the List of Interchangeable Terms stemmed directly from our CUSMA negotiations, which included wording around the standardization of Drug Facts Tables.  We are pleased the terms in the list expand beyond the terminologies in US 21 CFR and extend to Product Information tables for natural health products.

 

Here is the bulletin with more information: New regulatory tools: Monograph combination guide & List of interchangeable terms