On March 28, 2023, Health Canada issued guidelines for the approval and control of the production and pre-release of infant formula and human milk fortifier, in order to encourage manufacturers to accurately understand the relevant Canadian policies and regulatory requirements, and to prepare for the production of products and the submission of pre-release review materials. The guides are as follows:

1) Guide on the sale of human milk fortifiers

2) Guide for the preparation of infant formula and human milk fortifier premarket submissions

3) Scientific evidence requirements for nutritional adequacy of preterm infant formulas and human milk fortifiers

4) Scientific evidence requirements for nutritional adequacy of term infant formulas

5) Growth and tolerance clinical trial protocol - preterm infants

6) Growth and tolerance clinical trial protocol - healthy term newborn infants

7) Good manufacturing mractices for infant formula

8) New manufacturing facility requirements - infant formulas and human milk fortifiers

Learn more via: https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/infant-formula-human-milk-fortifier.html