145 new procurators or key enterprises of traditional Chinese medicine in SFDA

Medical network reported on June 29 that the State Food and drug administration has added 145 new procurators, covering 31 provinces, cities and autonomous regions except the State Administration A new round of drug inspection storm is coming Yesterday (June 28), the State Food and Drug Administration issued the notice of the office of the State Drug Administration on the announcement of the list of newly appointed national GMP inspectors (hereinafter referred to as the notice) ▍ in order to further strengthen the team and capacity-building of drug inspectors and promote the on-site inspection of drug production enterprises, the notice of 145 new prosecutors of the State Food and drug administration has proposed that Pei zhene and other 145 new inspectors should be appointed as the national GMP inspectors The national drug inspector certificate is hereby promulgated and issued It can be imagined that with the further expansion of the team of drug inspectors, the strength and frequency of on-site inspection of drug manufacturers will be enhanced Previously, the State Food and drug administration has published the 2018 drug tracking inspection plan On June 4, the State Food and Drug Administration issued the notice of the State Food and Drug Administration on matters related to the 2018 national drug tracking inspection (No 35, 2018), and formulated the 2018 drug tracking inspection plan The annual plan covers 201 pharmaceutical manufacturers Among them, there are 38 enterprises with more problems found in the national random inspection in 2017, 40 vaccine biological products manufacturers, 28 blood products manufacturers, 15 anesthesia, psychotropic drugs and drug precursor manufacturers, 60 newly approved injection generic drug manufacturers and 20 special inspection manufacturers In addition, the State Food and drug administration has made it clear that it will continue to increase the intensity of flight inspection, and at the same time, according to the needs of key regulatory work, risk monitoring and evaluation results, timely increase the list of inspected enterprises For the enterprises with serious problems found in the flight inspection in 2017, the methods of "review" are adopted, focusing on the implementation of rectification after the last flight inspection It can be seen that the drug companies that have not been inspected and the drug companies with more problems found in the previous year's flight inspection may be the key objects of prosecution In addition, compared with 2017, the strength of flight inspection in 2018 will continue to increase ▍ traditional Chinese medicine preparation enterprises or inspection focus: on June 8, the State Food and Drug Administration issued the 2017 annual drug inspection report According to the report, 428 GMP follow-up inspections (478 times) were completed in the whole year, a year-on-year increase of 234% Among them, 37 enterprises, accounting for 8.6%, and 108 enterprises sending warning letters, accounting for 25%, were found to be unqualified in the GMP follow-up inspection in 2017 The specific distribution is as follows: in 2017, 57 GMP flight inspections were carried out It covers 21 provinces (cities) including Jilin, Sichuan and Fujian, including 5 biological products manufacturing enterprises (including blood products), 14 common chemical drug manufacturing enterprises, 28 traditional Chinese medicine preparation manufacturing enterprises, 7 traditional Chinese medicine decoction pieces manufacturing enterprises and 3 traditional Chinese medicine extract manufacturing enterprises It is worth noting that of the 57 flight inspections carried out in 2017, the highest proportion was in traditional Chinese medicine preparation manufacturing enterprises, accounting for 49% of the total flight inspection work The proportion of Chinese herbal pieces is about 12%, that of common chemicals is about 25%, and that of biological products is about 9% In the whole year, 39 enterprises were found to have problems in flight inspection, accounting for about 68%, among which 27 enterprises with serious problems asked the Provincial Bureau to withdraw the GMP certificate or file a case for investigation By analogy, in addition to the further increase in the frequency of flight inspection, traditional Chinese medicine preparation enterprises may still be the focus of flight inspection Annex: list of newly appointed national GMP inspectors in 2018 1 Pei zhene and Zhang Shengyu in Beijing (2 people) 2 Dong Xiaoming and Zhang Qiang in Tianjin (2 people) 3 Huang Lihui, Zhang Yunzhe, Qi Pengfei and Yang Danya in Hebei Province (4 people) 4 Liu Dong and Li Lixia in Shanxi Province (2 people) 5 Inner Mongolia Autonomous Region (3 people) Zhang Guixia, sun Weiwei, Zhao Ruifang 6 Liaoning Province (3 people) Li Songbo, Li Xueliang, Wang Jiaonan 7 Jilin Province (4 people) Deng Huimin, Yan Dongmei, Li Jingxin, Chen Bing 8 Heilongjiang Province (2 people) Wang Yu, Wang renpeng 9 Shanghai City (6 people) Yang Yang, Liu Lu, Zhu Zhu, Liang Ye, Wang Fangmin, Zhu Juan 10 Jiangsu Province (3 people) You Qi, Zhang Wei, Yang Yaping 11 Zhejiang Province (4 people) Xu Chao, he Linwang, Wang Ping, Wang Huiqun 12 Anhui Province (2 people) Wang Pu, Zhang Yong 13 Fujian Province (3 people) Chen Sujuan, Yuan Jianlong, Fang Xiaowei 14 Liao Huijun, Liu Bin, Chen Haiqing, Jiangxi Province (3 people) 15 Wang Xinjian, Zhao Yan, zongfengyu, Li Xia, Fang Guodong, Shandong Province (5 people) 16 He Bin, Wang Yingju, Wan Jia, Jia Yurui, Xin Feng, Henan Province (4 people) Chen Han, Luo Xiang, Zhang Qing, Fu Yilin 18 Lin Xinwen, Li Changlin, Wen Jifu 19 Wen Hao, Mo Jieli, Wu Zhen 20 Liu Jicheng, Lin Hua 21 Sun Xiangfu, Fu Yanfei, Zhu Ling in Hainan 22 Chongqing (4 people) Zhao Lian, you Xiaojie, Dong Ling, Li Linke 23 Sichuan (3 people) Gong Yingjie, Du Yu, Zhang Lei 24 Guizhou (2 people) Zhang Zhiyu, Liu Junhong 25 Yunnan (3 people) Wang Dan, Yang Meifeng, Tang Kemin 26 Tibet Autonomous region (2 people) Li Hailiang, CI yong27 Zhan Yangyi, Zhou Ying, Yao Xiong, Shaanxi Province (3 people) 28 Chaiye, Li Yi, Li Anping, Gansu Province (3 people) 29 Zhang Rongge, Zhang Ning, pan Ping, Liu Xueliang, Zhang Yuchen, Jiao Zhengping, Qinghai Province (6 people) 30 Dong, Ningxia Hui Autonomous Region (2 people) Ying, LV Li 31 Xia Tao and Jia erheng yusufu of Xinjiang Uygur Autonomous Region (2 people) 32 Ling Yun and Ma Changming of Xinjiang production and Construction Corps (2 people) 33 State Drug Administration (18 people): Fang Zhao, Hu zenggi, Guo Weiwei, Liu Xiaogang, he Danying, Li Weihua, Gao Yan and Yang Ting, Li Nan, Yan Keshu, Lin Changqing, Zhou Le, Zhang Ti Deng, Liu Meng, Shi Le, Zhang Gaotong, Wang Xiangyu, Jiang Lu 34 Ren Liping, Ding Xiaoli, Feng Lei (3 persons) 35 Drug examination center (2 persons) MA Kun, Han Wei 36 Examination Center (18 persons) Kuang Yanwei, Lin Maoquan, Han Tianjiao, Jia Na, Huang Ying, Li WuChao, Xu Fei, Zhang Ping, Lu De, Zhang Yimin, Li Shan, Ma Yansong, Wang Mengyuan, Kang Ying, Wang Lijie, Liu Cong, Liu Jinxin, Huang Xue 37 Information Center (1 person) Tian Yongliang 38 High Research Institute (1 person) Liao binchi 39 He Wei and Wei Liping, Health Bureau of logistics support department of the Central Military Commission