In order to regulate the registration and filing of health foods, the Administrative Measures on Health Food Registration and Filing came into force on 1 July 2016.
At the beginning of 2018, State Administration for Market Regulation (SAMR) approved three health food registration products from three companies. This is the first batch of health food registration products after the implementation of the regulation. At the end of 2018, seven health food registration products were approved.
Since 2019, the number of registration products is significantly higher than that of 2018. Up to September 2019, 12 batches of 153 health foods have obtained health food registration approval. In order to give enterprises better understanding of the registration status, CIRS has made a detailed analysis on the registered products.
1. The Number of Approved Health Food Registration Products per Month
Up to 24 September 2019, the number of approved health food registration products has reached 153 in 2019. Among them, all 153 products were domestic health food registration products.
Fig.1 The Number of Approved Health Food Registration Products per Month of 2019
2. The Number of Approved Health Food Registration Products in Different Application Year
The application time of 153 health food registration products covered from 2010 to 2015. The number of applied products reaches the peak in 2013, reaching 88 products, accounting for 57.52% of the total, followed by 2014 with the number of 50, accounting for 32.68% of the total. On the whole, the products that have been backlogged for several years are solved one after another.
Fig.2 The Number of Approved Health Food Registration Products in Different Application Year of 2019
3. The Numb er of Approved Health Food Registration Products in Different Regions
The number of approved health food registration products is varied in different regions (provinces, municipalities and autonomous regions) in China. Beijing and Guangdong rank the first respectively with 28 approved health food registration products each, accounting for 18.67% of the total respectively (The applicants of three health food registration products have not been announced, thus not included in the statistics).
Fig.3 The Number of Approved Health Food Registration Products in Different Regions of 2019
4. The Number of Approved Health Food Registration Products with Different Applicants
125 health food manufacturers have obtained health food registration certificates. Among them, Beijing Century Health Care Pharmaceutical Technology Co., Ltd., has got the largest number of registration certificates of health foods (5), followed by Shenzhen Huipusheng Technology Development Co., Ltd. with the number of 4 (The applicants of three health food registration products have not been announced, thus not included in the statistics).
Fig.4 Top 15 manufacturers in obtaining health food Registration Certificates of 2019
5. The Number of Approved Health Food Registration Products with Different Dosage Forms
The dosage forms of approved health food registration products include capsule, soft capsule, tablet, powder, beverage, oral liquid, granule, wine, tea, pill, and glue. The dosage form of approved health food registration products is mainly capsule, with the number of 44, accounting for 28.76% of the total, followed by soft capsule, tablet and powder with the number of 31, 27 and 26, accounting for 20.26%, 17.65% and 16.99% of the total, respectively.
Fig.5 The Number of Approved Health Food Registration Products with Different Dosage Forms of 2019
6. The Number of Approved Health Food Registration Products with Different Health Functions
Among the 153 approved health food registration products, 33 products lack health function information.
Among the 120 approved health food registration products (the health functions of these products have been announced), 112 products have one health function. The health function of these products is mainly enhancing immune, with the number of 80, accounting for 71.43% of the 112 products. 8 products have two health functions, the health functions of these products are mainly enhancing immune and alleviating physical fatigue, with the number of 3, accounting for 37.50% of the 8 products.
Among the 33 approved health food registration products (the health functions of these products have not been announced), it is speculated from the raw materials of the products that the health function is mainly enhancing immune. But the specific quantity of related products should be confirmed after the health functions are officially announced.
Fig.6 The Number of Approved Health Food Registration Products with Different Health Functions of 2019
CIRS Comments
Since the implementation of the Administrative Measures on Health Food Registration and Filing on 1 July 2016, the approval of the health food registration products has been stagnant. The changes in health food registration policy and state institutional reforms are the key reason for the significant increase and decrease in the approval number and registration duration of health food. Due to the convergence of new and old regulations, some backlog products need to be adjusted and improved according to the new policy. The release and implementation of the new policy and the reform of state institutions will affect the health food approval progress of competent authority.
Since 2019, 12 batches of 153 health food registration products have been approved. The approval speed is significantly higher than that of 2018, indicating that the health food registration approval has been steadily launched.
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Note:
Source of data: Health food Data Search System of State Administration for Market Regulation (SAMR) and new approval announcements.