SAMR Adjusts Generic Names of FSMP Products

China changes the generic names of FSMP products. For enterprises that have already registered a product, they do not need to submit a registration alteration application but will be required to change the labeling info and product instruction manual of all registered products within 12 months.

As revealed by SAMR Notice No.26, the generic names of FSMP products are adjusted as below, which came into effect on May 30th, 2019.

Analysis of the Adjustment of generic names

The term "formula food", previously used in the middle of the name, was moved to the end of the name.

Eg. "Special Medical Purpose Infant Formula Food Lactose Free Formula"

→ “Special Medical Purpose Infant Lactose Free Formula Food"

Delete the term "breast milk" in "Special Medical Purpose Infant Formula Food Breast Milk Nutrition Supplement".
Simplify the name by deleting terminology like "Nutritionally Incomplete" in "Special Medical Purpose Nutritionally Incomplete Formula Food Nutrient module" and "specific" in "Special Medical Purpose Formula Food for (xxx Disease) Specific Full Nutritional Formula".

Full English Version (a literal translation of the Chinese version)

*Terms highlighted in yellow are all deleted.

Generic name before the adjustment	Generic name after the adjustment
Special Medical Purpose Infant Formula Food Lactose Free Formula	Special Medical Purpose Infant Lactose Free Formula Food
Special Medical Purpose Infant Formula Food Low Lactose Formula	Special Medical Purpose Infant Low Lactose Formula Food
Special Medical Purpose Infant Formula Food Partially Hydrolyzed Milk Protein Formula	Special Medical Purpose Infant Partially Hydrolyzed Milk Protein Formula Food
Special Medical Purpose Infant Formula Food Extensively Hydrolyzed Milk Protein Formula	Special Medical Purpose Infant Extensively Hydrolyzed Milk Protein Formula Food
Special Medical Purpose Infant Formula Food Amino Acid Formula	Special Medical Purpose Infant Amino Acid Formula Food
Special Medical Purpose Infant Formula Food Premature or Low Birth Weight Infant Formula	Special Medical Purpose Premature or Low Birth Weight Infant Formula Food
Special Medical Purpose Infant Formula Food Breast MilkNutrition Supplement	Special Medical Purpose Infant Nutrition Supplement
Special Medical Purpose Infant Formula Food Amino Acid Metabolism Disorder Formula	Special Medical Purpose Infant Amino Acid Metabolism Disorder Formula Food
Special Medical Purpose Formula Food Nutritionally Complete Formula	Special Medical Purpose Nutritionally Complete Formula Food
Special Medical Purpose Nutritionally Incomplete Formula Food Nutrient Components	Special Medical Purpose Nutrient Components Formula Food
Special Medical Purpose Nutritionally Incomplete Formula Food Electrolyte Formula	Special Medical Purpose Electrolyte Formula Food
Special Medical Purpose Nutritionally Incomplete Formula Food Thickener Components	Special Medical Purpose Thickener Components Formula Food
Special Medical Purpose Nutritionally Incomplete Formula Food Liquid Formula	Special Medical Purpose Liquid Formula Food
Special Medical Purpose Nutritionally Incomplete Formula Food for Amino Acid Metabolism Disorder	Special Medical Purpose Amino Acid Metabolism Disorder Formula Food
Special Medical Purpose Formula Food for (xxx Disease) Specific Full Nutritional Formula	Special Medical Purpose ( xxx Disease) Full Nutritional Formula Food

What should enterprises do?

	Types of enterprises	What should you do
1	Haven't submitted the registration application for FSMP products	Adjust the generic name in accordance with the notice.
2	Have got the registration certificate	No need to submit the alteration application for the name. SAMR will adjust the generic names of approved products and will inform enterprises to pick up the new registration certificates. However, enterprises need to change your labeling info and product instruction manual into new ones within 12 months, (starting from the effective date of this notice May 30th, 2019). Products that used the old version of labeling and product instruction manual can be sold until the expiration date.
3	The registration application or alteration application of FSMP products are under review	There's nothing you have to do. SAMR will adjust the generic names of products during the review.