Status Quo of China’s FSMP Registration in 2023 H1

According to the data from Special Food Information Query Platform, 24 food for special medical purposes (FSMP) products were granted registration approval in 2023 H1. Among them, one imported product was approved:

Company name	Product name	Country
Nutricia Cuijk B.V.	Pepti Junior extensively hydrolysed milk protein infant formula for medical purposes	The Netherlands

From 2019 to 2023, 2023 H1 has seen the highest number of FSMP products gained approval, indicating that the State Administration for Market Regulation (SAMR) is prioritizing registration work this year.

China FSMP Registration in H1: 2019-2023

FSMP could be classified into products designed for infants (0-12 months) and products for people aged above 1 year. The latter type occupies the majority of approved products, with 20 gained approvals, compared with 4 approvals for the former type. Additionally, 2023 H1 saw the approval of the first thickening component, showing the diversity of registered FSMP types.

FSMP Products Approved for Registration in 2023 H1

FSMP products for people aged above 1 year	Nutritionally complete foods	12
	Protein components	4
	Carbohydrate components	2
	Liquid formula	1
	Thickening components	1
	Total	20
Infant formula for special medical purposes (0-12 months)	Extensively hydrolysed milk protein infant formula	1
	Lactose free infant formula	1
	Premature or low birth weight infant formula	1
	Partially hydrolysed milk protein infant formula	1
	Total	4

The FSMP types listed above are based on the GB standards related to FSMP products. Please refer to the following articles for more information on the current framework of FSMP product types:

An overview of FSMP registration statistics

Up until June 30, 2023, China has approved 118 FSMP products. Despite only at halfway through the year, the number of registered FSMP products has already surpassed the annual totals of many previous years. Besides, since 2020, the annual registered FSMP products for people aged above 1 year has consistently surpassed those of infants.

FSMP Products Approved for Registration: 2017-2023H1

By the end of June, 2023, 30 imported FSMP products have been registered in China, with 9 originated from the Netherlands. Chinese products account for the majority of registered FSMP products, making up 74.6% of the total.

FSMP Products Approved for Registration: By Country

In total, 75 FSMP products for people aged above 1 year and 42 FSMP products for infants have received registration approval. Within registered FSMP products for people aged above 1 year, the most registered product type is nutritionally incomplete food. Within FSMP for infants, the most registered product type is premature or low birth weight infant formula.

For more details, please refer to Chinese Mainland: Food for Special Medical Purpose Registration.

All FSMP Products Historically Approved for Registration: By Product Type

FSMP products for people aged above 1 year	Nutritionally complete foods	35
	Nutritionally incomplete foods	39
	Electrolyte formula	14
	Carbohydrate components	10
	Protein components	9
	Liquid formula	2
	Thickening components	1
	Fat components	1
	Amino acid metabolism disorder formula	1
	Phenylketonuria formula	1
	Specific nutritionally complete foods	1
	Nutritionally complete formula for tumour patients	1
	Total	75
Infant formula for special medical purposes (0-12 months)	Premature or low birth weight infant formula	14
	Lactose free infant formula	12
	Partially hydrolysed milk protein infant formula	7
	Extensively hydrolysed milk protein infant formula	3
	Infant nutrition supplement	4
	Amino acid infant formula	2
	Phenylketonuria infant formula	1
	Total	43

In a recent reply to questions raised by the industry, SAMR states that it will expedite the revision of the Administrative Measures for Registration of Special Medical Purpose Formula Foods. Stakeholders can keep an eye on future official publications.

Notes:

Data are sourced from Special Food Information Query Platform. As the database may not provide real-time updates, there may be inconsistencies with the current regulatory situation.

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