Domestic dominance: 98% of China’s health food filing approvals go to home-grown firms

By Tingmin Koe

- Last updated on GMT

In the past 1.5 years, the Chinese health food filing system had approved 1,783 health food filings.  ©Pixabay
In the past 1.5 years, the Chinese health food filing system had approved 1,783 health food filings. ©Pixabay

Related tags Health food Regulation Import

Ninety-eight per cent of the approved health food filings in China over the last 18 months went to domestic firms, a Chinese regulatory consultancy has found.

A total of 1,783 health foods have obtained China’s health food filing certificates in the 1.5 years from July 2017 untill December last year, the report by CIRS Group said.

Only 33 went to foreign firms, while the remaining 1,750 (98%) went to Chinese domestic firms.

Among the approved imported products, most came from the US companies (18), followed by Australian companies (2). The US companies included Mega Nutra and A&Z Pharmaceutical, while the Australian firms were Swisse and Ausnatures Pharmaceuticals.

As for domestic firms, Weihai Baihe Biology Technology topped the list with 80 approvals, while BY-HEALTH notched-up 72.

The number of health food filing approvals peaked at 251 in December last year, however, all of these approvals were awarded to domestic manufacturers.  

In the other months, the number of approved filing was about 100 to 150.  

The health food filing system is meant to simplify the procedures of administrative examination. The other route to enter China’s supplement brick and mortar market is via the health food registration system, otherwise known as “blue-hat” registration.

Obtaining the health food filing or registration is the most crucial process in entering the Chinese domestic market, but it is still seen as cumbersome by many international firms, which prefer to stick to cross border e-commerce channels.

Manufacturers could proceed to import customs clearance after obtaining health food registration or filing.

There are however, key differences between the filing and registration systems.

Only basic vitamins and minerals are permitted to go through the filing system, while all other types of health food will need to go through the registration route.  

Also, filing requires a shorter duration and a lower cost. The estimated time needed to complete obtain filing approval is about six months, while that of the registration route is two to three years.

Most common types of supplements

Out of the 1,750 domestic health food filing, most of the approved filing goes to single nutrient supplements (45.5%), followed by supplements containing two types of nutrients (27.7%), then supplements containing multiple nutrients (26.7%).

Vitamin C is the most common single-nutrient supplement, while the combination of Calcium and Vitamin D is most common for two nutrients supplement, and multi-vitamins and minerals supplements are the most popular multi-nutrients supplements.

A similar trend is also observed for the imported health food filing products.


As the number of raw materials permitted for health food filing are limited, the report noted that the system may lead to the creation of similar products, which may intensify market competition.

 “The filing system may lead manufacturers to producing similar products due to the restrictive raw materials and excipients, and the competition will be getting tougher,”​ the report said.

However, the report expected the number of health food permitted for filing to increase, which means that more types of supplements could be approved via the filing route.

 “It can be expected that with the expanding of Health Food Raw Material Directory, Excipient Directory and filing dosage forms, more products will turn to health food filing, and enterprises will have more choices in terms of product formula and dosage forms.”

Dosage formats

In terms of dosage forms, tablets are the most common, accounting for 57.4% of all domestic health food filing products.

This is followed by soft capsules, which took up 27.2% of the market.

Whereas for imported health food filing products, tablets (45.5%) are the most common, followed by oral liquids (33.3%).  

At present, only five types of dosage forms are accepted for health food filing, they are tablet, hard capsule, soft capsule, oral liquid, and granule.

Previously, major Chinese supplement manufacturer Sirio Pharma said that​ functional gummies, which currently needs to undergo “blue hat” registration, could undergo health food filing soon. The firm thus expects to see a boom in China’s functional gummy market.

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