The Administrative Measures on Health Food Registration and Filing came into force on 1 July 2016 (hereinafter referred to as “the Measures”). In the early stage of the implementation of the Measures, due to the changes of relevant policies, the progress of health food registration was relatively slow. In 2018, only 10 products were approved for the registration. Fortunately, it seems to be smooth in 2019: there were 342 products obtaining the health food registration approval this year. In order to provide enterprises a better understanding of the registration status, CIRS summarized and made a detailed analysis on the registered products as below.
1. The Number of Health Food Being Approved for Registration per Month in 2019
The registered 342 health foods are all domestic products, and the number of approved products in each month is demonstrated in the figure below:
Fig.1 The Number of Approved Products per Month in 2019
2. The Acceptance Time (as years) of the Approved Products
The 342 products have been accepted by the former CFDA in the past few years (from 2010 to 2016), and was mainly in 2014, with the number of 170, accounting for 49.71% of the total, followed by 2013 with the number of 142, accounting for 41.52% of the total. The details are as the figure below:
Fig.2 The Number of the Products Accepted in Different Years
3. The Number of the Approved Products in Different Regions
The number of the approved products is varied in different regions (provinces, municipalities and autonomous regions) in China. Beijing has the most, with the number of 61, accounting for 17.84% of the total, followed by Guangdong, with the number of 56, accounting for 16.37% of the total. (Note: there are three products whose applicants have not been announced, thus, they are not included in the statistics)
The Number of the Approved Products in Different Regions
4. The Number of the Approved Products in terms of Different Applicants
The 342 products are from 268 health food manufacturers. Among them, Beijing Century Health Care Pharmaceutical Technology Co., Ltd. has got the largest number of registration certificates (10), followed by By-Health Co., Ltd. with the number of 6. (Note: there are three products whose applicants have not been announced, thus, they are not included in the statistics)
Fig.4 Top 16 manufacturers in obtaining health food Registration Certificates in 2019
5. The Number of the Approved Products in terms of Different Dosage Forms
The dosage forms of the approved products include capsule, tablet, soft capsule, powder, oral liquid, granule, beverage, wine, tea, pill, glue, extract and candy, and are mainly capsules, with the number of 99, accounting for 28.95% of the total, followed by tablets, soft capsules and powder with the number of 71, 61 and 49, accounting for 20.76%, 17.84% and 14.33% of the total, respectively.
Fig.5 The Number of the Approved Products in Different Dosage Forms
6. The Number of the Approved Products in terms of Different Health Functions
Among the 342 products, the health functions of 244 products have been officially published, include: 1) 218 products with single health function, which is mainly enhancing immune, with the number of 139, accounting for 63.76% of the 218 products; 2) 19 products with two health functions, which are mainly enhancing immune and alleviating physical fatigue, with the number of 8, accounting for 42.11% of the 19 products; 3) 7 products with the functions of supplementing vitamins/minerals.
The health functions of the remaining 98 products have not been published yet, while it could be speculated from their raw materials that, the health function is mainly enhancing immune.
Fig.6 The Number of the Approved Products in terms of Different Health Functions
7. CIRS Comments
Due to the change of health food registration policy and the institutional reform, the registration work of health food has been stagnant. Compared with 2018, however, much progress has been made. The number reached 342 in 2019. It indicates the improvement on the implementation of the new health food regulations, and the products that have been backlogged for several years are solved one after another. It is believed that the registration work on health food will also be carried out smoothly in 2020.
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