Interpretation of annual report (4): in 2017, there were 237 protected varieties of traditional Chinese medicine in China

[China Pharmaceutical network industry trends] on April 2, the State Food and Drug Administration issued the 2017 annual report on food and Drug Administration Statistics (hereinafter referred to as the annual report) Through the data about medicine in the annual report, we can see the basic development status of the medicine industry in 2017, and the author has a series of interpretations on this In the previous article "interpretation of annual report (3): China's innovative drugs will usher in the golden age in 2018", the author mainly analyzes the drug registration in 2017 This paper will focus on the analysis of the protection of traditional Chinese medicine varieties in 2017 According to the protection of traditional Chinese medicine varieties in the annual report, as of the end of November 2017, there were 237 certificates of traditional Chinese medicine varieties, including 110 varieties declared for the first time, 12 of the same varieties and 115 of extended protection period Compared with the data of previous years: as of the end of November 2016, there were 267 certificates of protected varieties of traditional Chinese medicine, including 120 first applied varieties, 15 same varieties and 132 extended protection periods; as of the end of November 2015, there were 317 certificates of protected varieties of traditional Chinese medicine, including 114 first applied varieties, 17 same varieties and 186 extended protection periods It can be found that the number of certificates of protected varieties of traditional Chinese medicine decreased year by year, the number of first declared varieties increased, while the number of the same varieties and extended protection period decreased And according to the recent CFDA database information of traditional Chinese medicine protection varieties, up to now, only 265 of the nearly 165000 drugs in China have been listed as traditional Chinese medicine protection varieties, of which 51 varieties have reached the end of the protection period before the end of 17 years, and only 214 varieties remain in the protection period, which shows that the traditional Chinese medicine protection varieties in China are very scarce In order to protect the low-level duplication of traditional Chinese medicine varieties, improve the disordered competition of enterprises, and promote the modernization, intensification and scale development of traditional Chinese medicine industry, China has also formulated corresponding measures It is understood that the protection system of traditional Chinese medicine varieties in China is a kind of protection system that the national drug supervision and administration department only allows enterprises to obtain the certificate of Protected Traditional Chinese medicine varieties within a certain period of time according to law According to the protection period of national traditional Chinese medicine varieties, the protection period of traditional Chinese medicine varieties is also different Among them, the first-class protected varieties of traditional Chinese medicine are 30 years, 20 years and 10 years respectively, and the second-class protected varieties of traditional Chinese medicine are 7 years The approved protected varieties of traditional Chinese medicine are limited to the production of enterprises that have obtained the certificate of protected varieties of traditional Chinese medicine within the protection period For example, not long ago, the State Food and Drug Administration issued the notice on protected varieties of traditional Chinese medicine (No 11), approving five varieties of traditional Chinese medicine produced by five enterprises to be listed as the "first protected variety of traditional Chinese medicine", with a protection period from February 24, 2018 to February 24, 2025 But there are also cases of prolonging the protection period of these enterprises' production varieties For example, on February 24 this year, CFDA announced the announcement on the protected varieties of traditional Chinese medicine (No 11 of the extended protection period) (No 25 of 2018), which extended the protection period of five varieties, including Tongluo Shenggu Capsule produced by Haizheng pharmaceutical and golden voice Kaiyin capsule produced by Xi'an Beilin pharmaceutical It can be said that these products continue to be on the list, which is the result of the affirmation of the drug efficacy and good market performance In general, the implementation of measures related to the protection of traditional Chinese medicine varieties is conducive to improving the quality of traditional Chinese medicine varieties, further protecting the legitimate interests of traditional Chinese medicine manufacturers, promoting more orderly competition in the traditional Chinese medicine market, and bringing more vitality to the traditional Chinese medicine industry.