The Status Quo of FSMP Registration as of 2020 H1

FSMP registration during 2020 H1

According to SAMR data, eight food for special medical purposes products (FSMP) obtained China’s registration approval during the first half of 2020. Seven of them are domestic products and the other is imported from the Netherlands. Nutritionally complete formula accounts for the majority of the overall approval in 2020 H1, representing 75%.

The amount of FSMP registration approval declined compared with the same time last year. The outbreak of COVID-19 at the beginning of 2020 is deemed as the major factor that postponed the special food registration (click here for the details).

It is noteworthy that four products failed the registration this year (all domestic products), which are:

• 伊正佳™ nutritionally complete formula

• 赛速康nutritionally incomplete formula food (electrolyte formula food)

• 沭泰electrolyte formula food

• 美德能舒闲宁® nutritionally complete formula food

The overview of FSMP registration

As of May 15, 2020, China has granted registration approval of 51 FSMP products, and domestic products account for 43% of the total registration. According to the product information unveiled by SAMR, 90% of those approved products are in powder form.

In terms of the product type, infant formula food for special medical purposes represents 60.8%, and quite a few of them are infant premature or low birth weight formula. FSMP targeting at the population over 1-year-old could be classified as nutritionally complete formula, nutritionally incomplete formula food and specific nutritionally complete formula. Currently, none specific nutritionally complete formula product has won approval.

Nestlé group obtained the most FSMP registration certificates in China, amounting to 11 products.

It may be harder to get FSMP registration certificate in 2020

From my personal perspective, the amount of FSMP registration approval in 2020 may not exceed that in the last year. On the one hand, the COVID-19 has somewhat postponed the technical review of the competent authority in the first half year, and the pandemic may also affect the registration schedule of some companies.

In May this year, infant related food safety crsis happened again in China, which is associated with the consumption of a solid beverage marketed and sold as an FSMP (click here for the details). Later on, the competent authority at all levels immediately started the specialized campaign to crack down on false advertising and illegal sales. In this case, SAMR may place more emphasis on the market supervision of FSMP in this year.

Additionally, China consulted on Special Food Registration Onsite Inspection Requirements in July 2019. If China passes the consultation draft this year, it will be harder to get the product approval since onsite inspection will become a mandatory step.