How about the acceptance and approval of TCM 1-8 varieties? Let's look at the analysis.

Traditional Chinese medicine refers to the medicinal substances and preparations used under the guidance of traditional Chinese medicine theory The measures for the administration of drug registration (Decree No 28) issued by the State Food and Drug Administration on July 10, 2007 clarifies the registration classification and description of traditional Chinese medicine, and stipulates that 1-6 categories of traditional Chinese medicine are new drugs, and 7 and 8 categories are declared according to the new drug application procedures Registration and classification of traditional Chinese medicine: Category 1 of traditional Chinese medicine: the effective ingredients and preparations extracted from plants, animals, minerals and other substances that are not marketed in China Traditional Chinese medicine class 2: newly discovered medicinal materials and their preparations Category 3 of traditional Chinese medicine: new substitutes of traditional Chinese medicine materials Traditional Chinese medicine 4 categories: new medicinal parts and preparations of traditional Chinese medicine 5 categories of traditional Chinese medicine: effective parts and preparations extracted from plants, animals, minerals and other substances that are not marketed in China Category 6 of traditional Chinese medicine: compound preparation of traditional Chinese medicine and natural medicine not marketed in China Category 6.1: compound preparation of traditional Chinese medicine; category 6.2: compound preparation of natural medicine; category 6.3: compound preparation of traditional Chinese medicine, natural medicine and chemical medicine Category 7 of traditional Chinese medicine: the preparation that changes the way of administration of traditional Chinese medicine and natural medicine that has been sold on the market in China 8 categories of traditional Chinese medicine: change the preparations of traditional Chinese medicine and natural medicine dosage forms that have been sold on the market in China (9 categories of traditional Chinese medicine are generic drugs.) Looking at the acceptance and approval of 1-8 kinds of traditional Chinese medicine in 2015, the drug regulatory department accepted 3 kinds of 1 kinds of traditional Chinese medicine, 5 kinds of 5 kinds of traditional Chinese medicine, 58 kinds of 6 kinds of traditional Chinese medicine, 1 kind of 7 kinds of traditional Chinese medicine, 7 kinds of 8 kinds of traditional Chinese medicine, 0 kinds of 2-4 kinds of traditional Chinese medicine; approved 26 kinds of 6 kinds of traditional Chinese medicine, 1 kind of 7 kinds of traditional Chinese medicine, 42 kinds of 8 kinds of traditional Chinese medicine, 0 kinds of 1-5 kinds of traditional Chinese medicine (according to the number of types of 1 kind of traditional Chinese Medicine) Other categories are calculated according to acceptance number; data source: drug intelligence data) 1、 Acceptance and approval of category 1 Traditional Chinese medicine in 2015 category 1 Traditional Chinese medicine refers to the natural single ingredients and preparations extracted from plants, animals, minerals and other substances not included in the national drug standards, and the content of the single ingredients should account for more than 90% of the total extract In 2015, the drug regulatory department accepted 3 TCM category 1 varieties, including forsythin from Guangdong Laien Pharmaceutical Research Institute Co., Ltd., hydroxysafflor yellow a from Ruiyang Pharmaceutical Co., Ltd and Bailong wine from Chongqing Bailong cancer treatment drug research institute In 2015, the number of TCM category 1 varieties approved by the drug regulatory department was zero 2、 Acceptance and approval of five categories of traditional Chinese medicine in 2015 five categories of traditional Chinese medicine refer to the effective parts and preparations composed of one or more categories of ingredients extracted from a single plant, animal, mineral and other substances which are not included in the national drug standard, and the content of the effective parts shall account for more than 50% of the extract In 2015, the drug regulatory department accepted 5 kinds of traditional Chinese medicine and approved 0 kinds of traditional Chinese medicine and 5 kinds of traditional Chinese medicine The details are shown in Table 1: in 2015, the drug regulatory department accepted 5 kinds of traditional Chinese medicine and 3 kinds of traditional Chinese medicine and 6 kinds of traditional Chinese medicine and 6.1 kinds of traditional Chinese medicine compound preparation should be formulated under the guidance of traditional medicine theory It mainly includes: Traditional Chinese medicine compound preparation from ancient classic prescriptions, traditional Chinese medicine compound preparation whose main treatment is syndrome, traditional Chinese medicine compound preparation whose main treatment is disease syndrome combination, etc 6.2 the compound preparation of natural drugs should be formulated under the guidance of modern medical theory, and its indications should be expressed in modern medical terms 6.3 the compound preparations composed of traditional Chinese medicine, natural drugs and chemicals include traditional Chinese medicine and chemicals, natural drugs and chemicals, and the compound preparations composed of traditional Chinese medicine, natural drugs and chemicals In 2015, the drug regulatory department accepted a total of 58 varieties of traditional Chinese medicine (6 categories), and all four varieties of drug research in Xinjiang Uygur Autonomous Region were accepted, ranking first; Jiangsu Kangyuan Pharmaceutical Co., Ltd., Yabao Pharmaceutical Group Co., Ltd and Jichuan Pharmaceutical Group Co., Ltd each had two varieties accepted (as shown in Table 2); the remaining varieties were under the Institute of traditional Chinese medicine, Chinese Academy of Chinese medicine Shaanxi Institute of traditional Chinese medicine, Chongqing Huasen pharmaceutical and other 48 enterprises In 2015, the drug regulatory department approved a total of 26 kinds of traditional Chinese medicine, including 26 enterprises including China Pharmaceutical University, Shandong dong'ejiao, Harbin Yikang pharmaceutical, etc Table 2: in 2015, the drug regulatory department accepted a total of 58 kinds of traditional Chinese medicine (5 categories) 4 In 2015, the acceptance and approval of 7 kinds of traditional Chinese medicine (7 categories) refer to preparations with different routes of administration or absorption sites changing with each other In 2015, the drug regulatory department accepted a total of 7 kinds of traditional Chinese medicine, namely the Yaotongning plaster of Jingfukang Pharmaceutical Group Co., Ltd.; the 7 kinds of traditional Chinese medicine of Heilongjiang Chenggong Pharmaceutical Co., Ltd longxuejieshuan was approved for clinical application 5、 Acceptance and approval of 8 categories of traditional Chinese medicine in 2015 8 categories of traditional Chinese medicine refer to preparations that change the dosage form without changing the route of administration In 2015, the drug regulatory department accepted a total of 7 kinds of 8 kinds of traditional Chinese medicine, details are shown in Table 3; a total of 42 kinds of 8 kinds of traditional Chinese medicine were approved, belonging to 42 enterprises such as Henan furentang Pharmaceutical Co., Ltd., Shandong Sanjiu Pharmaceutical Co., Ltd and Shijiazhuang Yiling Pharmaceutical Co., Ltd Table 3: the special interface of the summit of 7 kinds of traditional Chinese medicine and 8 kinds of varieties accepted by the drug regulatory department in 2015: http://news.yaozh.com/zhuanti/detail.html? 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