Update on Monograph Initiative and Schedule

Posted Date: 29-July-2025

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

 

The following 6 monographs will be published on July 25, 2025:

 

 

Monograph from batch 1 (with a second consultation as part of batch 3)

 

  1. Green tea extract

 

Monographs not in batches

 

  1. Hydrocortisone – topical
  2. Serrapeptase
  3. L-Carnitine
  4. Ginkgo biloba
  5. Aromatherapy

 

In addition, NNHPD has made minor revisions to the following 5 monographs:

 

Dandelion:

  • Update to the combination rules.

 

Workout Supplements:

  • Addition of a combination rule when L-carnitine is combined with acetylcarnitine at Class II and III.
  • Addition of L-carnitine as a source ingredient for L-carnitine.
  • Exclusion of the uses or purposes associated with pregnancy from the Multi-vitamin/mineral Supplements monograph, since a cautionary or contraindication statement is required for pregnant women for workout supplements products.
  • Inclusion of the missing minimum single dose for caffeine.
  • Adjustment of the duration of use statements for L-arginine to allow for proper validation.

 

L-Arginine:

  • Adjustment of the duration of use statements for L-arginine to allow for proper validation.

 

Antioxidants:

  • Addition of L-carnitine as a source ingredient for L-carnitine.
  • Revision of the common names for green tea extract to match revisions to the single ingredient monograph and to the NHPID in order to ensure that it only includes green tea.
  • Revision to the quantity information for green tea extract to match the revisions to the single ingredient monograph.
  • Addition of quantity information for Goji fresh fruits, fresh juice, concentrated juice, and dried juice (Lycium barbatum) to address a request from industry and risk information linked to interaction with prescription medications.
  • Addition of the combination rule for alpha-Lipoic acid to match the single ingredient monograph.
  • Addition of a combination rule when L-carnitine is combined with acetylcarnitine at Class II and III.
  • Reference to the single monograph for Haematococcus pluvialis in Tables 6 and 7.

 

Cognitive function products:

  • Inclusion of the synthetic source information for L-5-HTP and theobromine.
  • Removal of the extract ratio for Ginkgo biloba to provide more flexibilities and match revisions made to the single ingredient monograph.
  • Addition of a combination rule when acetylcarnitine is combined with L-carnitine at Class II and III.

 

Here is the updated monograph schedule from Cosmetics Alliance.