FSMP in China: South Korean products accepted by Chinese authorities for the first time

By Tingmin Koe

- Last updated on GMT

China has approved a total of 35 FSMPs. ©Getty Images
China has approved a total of 35 FSMPs. ©Getty Images

Related tags FSMP China South korea

The Chinese authorities have accepted Foods for Special Medical Purposes (FSMPs) made by a South Korean firm for the first time.

Maeil Dairies was granted FSMPs approval for two of its products, namely ‘Maeil Lactose Free’, an infant lactose-free formula, and ‘Maeil Preemie’, an infant formula for premature and low birth weight infants.

Both products are catered to infants aged 0 to 12 months and are produced from the company’s Pyeongtaek factory, located in the Gyeonggi province.

Both formula contain a 1:1 ratio of DHA to ARA. 

‘Maeil Preemie’ works to improve digestion and absorption of fat in pre-term infants through the  lipid structure of the formula. Beta-palmitate is also added to increase the absorption of calcium.

Other than the two products, China’s State Administration for Market Regulation (SAMR) has also recently approved domestic firm Beingmate’s infant nutrition supplement.

The product, catered to pre-term and low birth weight infant, can be consumed together with breastmilk to improve nutrition intake.

China has now approved a total of 35 FSMPs, which is nearly twice as much than last December​, where only 18 products were approved.

Foreign firms still dominate

According to a study from Chinese regulatory consultancy REACH24H, the FSMP market in China is highly dominated by foreign enterprises, with 25 out of 35 (71.4%) of the registered products coming from overseas firms.

Netherlands is leading the pack for foreign companies with six FSMPs approved, while Germany, Spain, Switzerland, the UK and US followed, with three products each.

Similar to Maeil Dairies, Singapore firm SMC 21 is another which made it into the list with two FSMPs.

Most of the approved FSMPs cater to infants between 0 to 12 months old.

In view of the heavy concentration on infant formula products, another regulatory consultancy firm, Hangzhou Reach Technology Group (CIRS)  earlier pointed out that manufacturers could explore areas in elderly health.

The FSMPs segment was highlighted as one of the key areas where both dietary supplements and pharma firms are paying attention to, according to an interview​ that NutraIngredients-Asia​ conducted with Mintel recently.

In China, FSMP is meant for fulfilling the nutritional needs of patients who have problems ingesting food, digesting food and or are suffering from metabolic syndromes and specific illnesses.

Under successful conditions, firms will need to spend three years in going through the registration process, including preparing the documents and conducting clinical trials.

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