Update on Monograph Initiative

Posted Date: 9-September-2025

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

 

The NNHPD shared on August 28th, an update on the monograph update project. Our updated running-list of changes has been updated and may be accessed here.

Three monographs were published in the NHPID on August 29, 2025.

Monograph from batch 3

  1. Calcium-Potassium salt of Hydroxycitric acid

Monographs not in batches

  1. Malabar tamarind – Garcinia gummi-gutta
  2. Tomato extract

 Minor revisions to monographs previously updated

Angelica:

  • Fixed a few typos.
  • Added the preparation column in Table 1.
  • Added a missing common name in French.
  • Adjusted the third claim in French to add missing text (i.e. “aide à”).
  • Revised ‘consulter’ to ‘consultez’, ‘éviter’ to ‘évitez’ and ‘souffrez d’un ‘ to ‘avez un’ in French.

 

African wild mango:

  • Added the Class II and III rule associated with weight management claims.
  • Fixed a few typos.
  • Revised ‘consulter’ to ‘consultez’, ‘cesser l’utilisation’ to ‘cessez d’utiliser’ and ‘souffrez de’ to ‘avez le’ in French.
  • Updated the Product Facts Tables.

 

Aloe – Topical:

  • Fixed a few typos.
  • Added the preparation column in Table 1.
  • Revised ‘consulter’ to ‘consultez’ and ‘cesser l’utilisation’ to ‘cessez d’utiliser’ in French.
  • Adjusted few references.

 

Blueberry:

  • Subtitle for the risk statement adjusted as combination of dried and fresh fruit is not permitted as per the combination rule.

 

Minor typos affecting validation were also fixed for the following 12 monographs

 

Note that since there are no changes to the content of these monographs, their publication dates have not been revised.

 

English only:

  • Dong quai
  • Gentian

French only:

  • 5-HTP
  • American ginseng
  • Burdock
  • Caraway (HTML version only)
  • Senna

Both English & French:

  • Athlete’s foot treatments
  • Beta-Glucan
  • Bilberry – oral
  • Black pepper (HTML version only)
  • Fixed oil products – oral