Statistics of Domestic Health Food Filing Products in China

On 27 July, 2017, Guangdong FDA issued the first domestic health food filing product of “SUNOTA Folic Acid Tablets”. Guangzhou SUNOTA Health Technology Co., Ltd got the first health food filing certificate in China. Thereafter, different provincial FDAs successively released the Filing Notices of health food products, and the number of filing products is increasing rapidly. At present, at least hundreds of domestic nutrient supplements have got the filing approval. However, since the ways and frequencies to publish filing products, and the published information are both different in different provincial FDAs, the complete information of the approved domestic filing products are still unavailable.

In order to help relevant enterprises have an overview of filing products in China, CIRS checked the websites of every provincial FDA in China, and counted the data of the filing products that have been officially released to the public for your reference.

1. Approval numbers of domestic health food filing products

Up to 28 February 2018, a total of 351 domestic filing products have been officially released to the public by different provincial FDAs in China. Among them, 100 products are from Guangdong province, which accounts for 28% of total. In addition, there are more than 50 products released to the public in Shandong province and Heilongjiang province as well.

The top 10 enterprises that get the domestic health food filing certificates are as follows. Among them, By-HEALTH Co., Ltd ranks No. 1, with 50 filing nutrient supplements (27 products of them are supplying multiple vitamins-minerals).

2. Specific information of the approved filing products

2.1 Numbers of approved filing products under different health functions

According to Figure 3, among the 351 approved filing products, 152 products are intended to “supply 1 nutrient”, which account for 43% of total. In addition, the products that intended to “supply 1 nutrient” and “supply 2 nutrients” account for 70% of total products. In summary, the health functions of the most approved products are simple.

In terms of the 152 filing products that only supply 1 nutrient, the health functions ranked the forefront are as follows. Among them, the health function of “supply vitamin C” takes the first place, which account for 30% of the 152 filing products.

In terms of the 92 filing products that supply 2 nutrients, 33 products of them are intended to “supply vitamin D + calcium”, which account for 36% of them. This shows that with the increasing number of health food filing products, enterprises will also face the problem of product homogenization.

2.2 Dosage forms of the approved filing products

Currently, according to Main Production Processes of Health Food Filing Products (Trial), there are only 5 dosage forms allowed to be used for health food filing, namely, tablets, hard capsules, soft capsules, oral liquids, and granules. The 351 approved filing products have covered all 5 dosage forms. Among them, 210 products are tablets (including tablets, chewing tablets, effervescent tablets), which account for 60% of total. On the other hand, products with the dosage form of hard capsules are in the least. At present, there are only 10 hard capsule filing products available.

3. Summary and suggestions

Health food filing is unprecedented in China. It is developed with the goal of simplifying the procedures of administrative examination, which will help to invigorate the market, and reduce the enterprise burden. With the approval of first domestic filing product, hundreds of products have got the filing approval in less than one year. It can be expected that with the expanding of Health Food Raw Material Directory, more products will turn to health food filing. However, from another point of view, the filing system may lead manufacturers to producing similar products because of the restrictive raw materials and excipients, and the competition will get tougher. Therefore, in order to enter the China market in the earliest, enterprises who intend to apply for health food filing are suggested to carry out the preparation as soon as possible.