Article 74 of the Food Safety Law stipulates that China implements strict supervision and management of special foods such as health foods, formula foods for special medical purposes (FSMP), and formula foods for infants and young children. At present, in addition to the "dual-track system" for registration and filing of health foods, FSMP and infant formula foods all implement the registration system. The COVID-19 epidemic hit in 2020. In the first half of 2020, what was the approval of special foods? Today, the registration department of Foodmate will comprehensively check the approval of special foods in the first half of 2020.

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Special food approval status

1. Infant formula food

In the first half of 2020, the pace of approval of infant formula foods has slowed. According to statistics, the State Administration for Market Regulation (SAMR) issued a total of 282 approval documents (decision letters) of infant formula milk powder product formula registration. Among them, 252 have been approved, of which registration changes account for the majority, 21 items were disapproved, and 9 items were unclear (unclear means that the registration decision pending information was announced, but until June 30, the relevant information could not be found on the "Special Food Information Query Platform" of SAMR), the relevant information is as follows:


Among the 30 formulas approved in the first registration, there are 9 imported formulas. At the same time, we have also made statistics on whether these 30 products have obtained organic certification. The relevant information is as follows:


2. Formula Foods for Special Medical Purposes (FSMP)

Since the implementation of the "Administrative Measures on the Registration of Formula Food for Special Medical Purposes" on July 1, 2016, there have been 51 FSMPs approved for registration until June 30, 2020. In the first half of 2020, a total of 8 products have been approved, which are mainly domestic products (7); a total of 6 products have not been approved, and 3 products have changed information. The relevant information is as follows:


3. Health Food

According to the "Administrative Measures for the Registration and Filing of Health Foods" issued by the former State Administration of Food and Drug Administration, starting from July 1, 2016, the management of health foods has changed from the previous single registration system to a "dual-track system", which is a combination of registration and filing. Therefore, we will conduct statistical analysis for you from the two aspects of "registration system" and "filing system".

3.1 Registration of health food

Affected by factors such as the "Administrative Measures for the Registration and Filing of Health Foods" (referred to as the Administrative Measures) implemented on July 1, 2016 and institutional reforms, there has been an overdue period for the approval of health foods, resulting in a backlog of product approvals. The currently approved new products are mainly products accepted before the implementation of the Administrative Measures, which are before July 1, 2016. In addition to newly registered products, the approval of registered health foods also includes approvals for renewal of registration, product information changes, and technology transfer.

In the first half of 2020, the official website of the National Medical Products Administration government service portal released a total of 2639 health food approval information, including 852 health food approval mailing details (including health food registrant name and address change application review results notice mailing information ) And 1787 information about health food approval documents.

Compared with the data of previous years, the number of product approvals in the first half of 2020 is larger, and the approvals are faster than in previous years. From the product information released in each month, the January-June period shows a decreasing trend, which may be related to the impact of the epidemic.


3.2 Filing health food

Due to different filing management departments, we have separately made statistics on imported health food filing and domestic health food information, as follows:

(1) Filing status of imported health food

In the first half of 2020, 10 imported health food filing certificates were issued, most of which are the products filed in 2019, and there are only 2 products with filing numbers starting with "食健备J2020". Due to the centralized release of filing information, we saw that on July 3, 30 imported health foods with filing vouchers were released. (Note: The 2020 filing certificate number has been released from "食健备 J202000000001" to "食健备J202000000033", of which "食健备J202000000020" has not been announced.)

(2) Filing status of domestic health food

In the first half of 2020, the market supervision and management departments of all provinces, autonomous regions, and municipalities directly under the Central Government issued a total of 436 product information with the filing certificate number "食健 G2020XXXXXXXX".


The impact of the epidemic on special food approval

In the first half of 2020, the overall number of approvals for special foods has decreased compared with the same period last year. In addition to the number of applications received in the previous period, it has also been affected by the epidemic.

From the perspective of product information preparation, the epidemic has prolonged the information preparation cycle. In particular, the information (such as inspection reports, relevant certification materials, etc.) that applicants need to cooperate with other agencies to provide has affected the progress of product applications.

From the perspective of product acceptance, on January 30, 2020, the “Announcement on Extending the 2020 Spring Festival Holiday and Other Related Matters in the Administrative Acceptance Service Hall of the National Medical Products Administration (No. 257)” notified the on-site office work and the submission of documents in the acceptance hall were suspended, and applicants changed to submit materials by mail. In addition, in March and April, Beijing had certain requirements on the number of office staff, and the workload of the staff in handling acceptance doubled. On May 22, 2020, "Announcement on the gradual restoration of on-site services at the Administrative Acceptance Service Hall of the State Drug Administration (No. 262)", notified that the on-site acceptance business will be resumed in the case of advance registration through the system. Product acceptance business has basically resumed.

From the perspective of technical review, on February 21, 2020, the Food Review Center of SAMR issued the "Announcement on the suspension of on-site inspection of special food registration during the epidemic prevention and control period". We all know that on-site inspection is a key review link of administrative approval items such as new product registration, so it also has a certain impact on the approval of special foods.

The epidemic has brought varying degrees of impact to all industries in 2020. With the gradual control of the epidemic, it is believed that the review and approval of special foods will be further accelerated in the second half of the year.

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