【文化周】2017年10月21日-22日,世中联主办第十四届世界中医药大会暨”一带一路”中医药文化周。地址：泰国曼谷；联系人及电话：邹建华 010-5865 0042/5865 0243。
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The public number sponsored by the China Association of traditional Chinese medicine information Specialized Committee, please click on the top of the circle of traditional Chinese medicine concern us.
May 4, 2017, Thursday, the 9th day of the fourth month of the Chinese lunar calendar, the year of the rooster – Chen jeongyujaeran nationalist revolution.
01CFDA printing and health care products for the record of available materials and the use of the provisions of the production process, work guide and other trial notice
Domestic and imported health food for the record to obtain access to the record management information system login account application
In May 2nd, CFDA released the official website of the provisions of the available materials and their use of health food products for the record (Trial) health food products for the main production process (Trial) health food filing guidelines (Trial) notice.
The pilot work guide pointed out that the production and management of health food, domestic health food should record to the location of provinces, autonomous regions and municipalities directly under the food and drug administration department proposed to obtain account record management information system login application; imported health food for record filing system login account, need to carry the producing country (region) issued by the competent government for the record department or legal services for overseas listed health food manufacturers qualification documents and contact authorization; the original registered product transfer record, shall apply to the administration of the technical review mechanism to apply.
The archival materials include health food registration form and legal liability undertaking, filing registration certificate, main product formulation materials, production process, material safety and health function evaluation materials and other 7 items.
The main products for the production process is applied to supplement vitamins, minerals and other nutrients of health food (nutritional supplements), divided into tablets, hard capsules, soft capsules, oral liquid, particles, etc..
The use of material requirements, materials shall not have any health hazards to the human body; not to conceal the products’spoilage for the purpose; not to conceal the quality defects of the product itself or processing or adulterate, forged for the purpose; the product itself does not reduce the health function and nutritional value; on the premise of achieving the desired results as may reduce the amount of the product in use; processing aids should be consistent with the standards for use of food safety standards of food additives.
02 Shanghai market regulatory reform, the food and Drug Administration or will be withdrawn?
Saibai blue analysis will set off the food and drug administration to change the mode of the storm
According to well-known public, Saibai blue reports, the recent news that the Shanghai municipal Party committee agreed that the establishment of the CPC Shanghai municipal market supervision and Management Committee, responsible for the Shanghai City Administration of Industrial and Commercial Bureau, bureau of quality and technical supervision, food and Drug Administration and other departments of the work of the party; at the same time cancel the Shanghai Municipal Bureau of quality and technical supervision, Shanghai Committee of CPC the food and Drug Administration committee. People’s Daily has published view, food safety supervision is typical of the Kowloon flood, industry and commerce, quality supervision, food and drug supervision departments in the three practice often overlapping functions, poor convergence, mutual shuffle, Absence defects. The big market regulatory reform attempt is to explore the transformation of government functions, further decentralization.
Tianjin city in July 2014 with the industry and commerce, food and drug administration, quality supervision departments of the three three in one established market and Quality Supervision Committee, and even earlier, Shanghai District of Shenzhen Pudong New Area, Zhejiang Zhoushan and the establishment of market supervision bureau of exploration of precedent, Saibai blue believes that the three in one in the city of Shanghai is likely to move the model in the municipalities directly under the central government after the implementation of promotion to the nation, there is no doubt that the national food and drug supervision mode change, will really set off a big storm.
Medical staff registration next year all electronic. The State Planning Commission and the State Administration of traditional Chinese medicine jointly issued on the day before the medical institutions, doctors and nurses electronic registration management reform guidance requirement, by June 2018, the full implementation of electronic registration management, covering all the medical institutions, doctors and nurses; by 2020, the basic completion of the use of electronic license issuing work. According to the schedule, by June 2017, the province started the electronic registration management reform pilot; by December 2017, more than 40% of the provinces and municipalities to carry out electronic registration management reform.
Sichuan province to carry out special inspection of traditional Chinese medicine extract. Sichuan provincial food and drug administration before the announcement, in the 6 months to carry out a special inspection of the use of Chinese herbal extract production. Check range: to extract of traditional Chinese medicine Chinese medicine production enterprises, focus on the group’s share, enterprise establishment, provincial enterprises set up pretreatment and extraction workshop in Sichuan province to carry out special inspection, and urge enterprises to carry out production in strict accordance with the GMP requirements; check the key ability, including the extraction process and formulation, feeding, approval procedures, process specification the contents of 18 parameters. Beijing Tongrentang, Tai Chi Group, the United States and China Pharmaceutical Co., Ltd. and other 28 companies are the focus of the inspection object.
1004 drugs or kicked out of Guangdong market. In May 2nd, the drug trade center in Guangdong Province issued publicity, the 1004 do not supply or not timely supply of medicines in the public within 10 days (as of May 12th 17) is still not timely delivery, according to the relevant provisions will be kicked out of the medical market in Guangdong for 2 years; the drug delivery is not timely, cancel 2 years distribution qualification. This publicity involves 135 pharmaceutical companies, including Baiyun Mountain, and other famous enterprises of traditional Chinese medicine.
Anhui food and drug administration intends to determine the pilot units of traditional Chinese medicine formula particles. In May 2nd, the Anhui provincial food and Drug Administration for 7 days of publicity in Anhui Province Chinese medicine granule pilot study to determine the unit, unit 6, namely: Anhui Huarun Limited by Share Ltd, Jinchan pharmaceutical Anhui Jiren Pharmaceutical Company Limited, Anhui Jiuzhou Fangyuan Pharmaceutical Co. Ltd., Limited by Share Ltd, Anhui Hua Tuo Chinese medicine Chinese medicine Limited by Share Ltd, glabellum Anhui unicooperate Pharmaceutical Co. ltd..
Chinese medicine real world clinical research technical specifications and other 3 groups of standard project. In May 2nd, the Chinese Medical Association issued a notice, approved by the Chinese medicine clinical research on real world technology standard, Chinese medicine physical conditioning, guide cancer pathogenesis theory of treating tumor clinical guide 3 group standard project.
Chinese medicine practitioners in Australia for the first time in the scope of legislation of Chinese medicine practitioners. According to the official website of Beijing University of Chinese Medicine news, recently, Beijing University of Chinese Medicine sent to Australia Chinese medicine center China TCM practitioners for the first time the Australian authorities issued the AHPRA Chinese Medicine – Chinese medicine and acupuncture – Chinese medicine practitioners permit. This is the first official review of the Australian government for the purpose of education and scientific research in China, can be engaged in the clinical application of Chinese medicine professional license.
Chinese medicine culture into Hebei Hengshui middle school. Recently, the State Administration of traditional Chinese medicine of traditional Chinese medicine in Hong Kong and Macao Cooperation Center for the Hebei Hengshui high school students A entitled health on their own — the culture of Chinese medicine and health report. The three report from the health standards and the cause of disease, traditional Chinese culture, traditional Chinese medicine describes a way of keeping good health, dynamic harmony between man and nature, the concept of yin and Yang and the five elements and three factors of the dialectical view of Chinese culture, and Chinese medicine acupuncture related knowledge and the domestic and foreign development trend, to enable students to fully understand Chinese medicine culture, feel the charm of traditional culture.
Trend of famous enterprises
Artemether raw material through the who PQ certification. In May 2nd, Kunming Pharmaceutical Group announced that a wholly-owned subsidiary of China Pharmaceutical WHO Wu received artemether on API PQ (production pre authentication) confirmation, related products have been included in the World Health Organization recommends purchasing list. This is the Chinese pharmaceutical pharmaceutical after the dihydroartemisinin dihydroartemisinin, and then go to a global procurement platform for PQ certification varieties.
20 listed Chinese enterprises in 2016 gross margin over 70%. According to the annual report of listed companies, as of April 28th, a total of 20 Chinese enterprises listed companies in 2016 gross margin of more than 70%. The gross profit margin of over 80% pharmaceutical companies a total of 5, namely: Kanghong Pharmaceutical (90.41%), jumpcan (85.24%), (84.51%), Qizheng Tibetan medicine (83.17%), Shanghai step pharmaceutical Kaibao (81.25%).
PR Newswire: first Chinese Yi medicine Longfa pharmaceutical stocks. According to the China pharmaceutical net reprint Newswire articles, in the production of brand-name products in Yunnan vitamin C Yinqiao Tablets and Chen Xianglu dew piece well-known pharmaceutical companies in Yunnan Longfa pharmaceutical before the date listed on the new board into the city, becoming the first Chinese Yi medicine shares. Chairman Jiao Jialiang introduction, Longfa pharmaceutical will fully leveraging the capital market, promote the China Yi medicine theory of construction market, product market, build healthy eco industrial chain in the field of medicine, health care, deep Yi medicine health industry. Statistics show that Longfa pharmaceutical was founded in 1967, formerly known as Chuxiong pharmaceutical factory, 1998 for the restructuring of the limited liability company; 2003 was acquired by Hongkong Longfa Pharmaceutical Group, and renamed Yunnan Longfa Pharmaceutical Co Ltd.
Tiansheng pharmaceutical IPO approved by the commission. Tian Sheng pharmaceutical May 2nd announcement, the listing application has been approved by the Commission, will not exceed 53 million shares of A 10 this month, the initial public offering, to raise funds to invest in technological transformation, oral solid preparation GMP non PVC soft bag large volume injection GMP technology, Tian Sheng (Chongqing) 4 projects of modern pharmaceutical logistics headquarters the base and the drug R & D center construction etc.. Tiansheng pharmaceutical currently has 77 kinds of drugs into the national essential drugs list, 152 kinds of drugs were included in the national health insurance directory, has two exclusive varieties yanshenjian capsule and Di Zhen granule. According to the media is expected from the same company A shares of sales volume and price earnings ratio, Tiansheng pharmaceutical market capitalization or 10 billion.
Pharmaceutical electricity supplier to shake hands: looking for herbs and medicine cheap strategic cooperation. Recently, the pharmaceutical B2B platform cheap medicine and Chinese herbal medicine B2B platform to find drugs in Beijing signed a strategic cooperation agreement. Through cooperation, looking for drugs can get the corresponding business shop service and cheap loans from financial services medicine cheap, but also for the user to provide more distribution channels; cheap medicine can find the perfect ingredients for Chinese traditional medicine and Chinese medicine category plate.
Pharmaceutical public opinion
3 companies in production and sales of counterfeit drugs \/ Ginkgo Biloba Leaves Extract Tablets. CFDA’s official website announced in May 2nd 3 companies production information administrative punishment \/ counterfeit drugs sales Ginkgo Biloba Leaves Extract Tablets case. Information display, Ningbo liwah pharmaceutical production of 63 batches of substandard drugs through inspection for Ginkgo Biloba Leaves Extract Tablets, Hubei Wushi pharmaceuticals and Heilongjiang Tianhong pharmaceutical production of a total of 25 batches of Ginkgo Biloba Leaves Extract Tablets were in accordance with the law for qualitative fake. According to the Drug Administration Law stipulates that the 3 companies, Ginkgo Biloba Leaves Extract Tablets approval documents were revoked.
Flight inspection failed, two companies were recovered GMP certificate. CFDA’s official website released May 2nd flight inspection bulletin, Henan Province, Jiangsu Hong Wah pharmaceutical Pingguang Xinyi (Jiaozuo) Chinese companies were withdrawn due to serious violations of the GMP certificate, and was punished. Bulletin shows, Hong Wah pharmaceutical enterprise material, production and file management, Chinese herbal medicine treatment before operation is not in accordance with the production process Huoxiangzhengqi pills; matt Xinyi (Jiaozuo) part of Huoxiangzhengqi pills pretreatment of traditional Chinese medicinal materials and preparation of the batch production record is not real, material management, quality control and quality assurance etc. can the effective implementation of drug GMP requirements, and there are many problems in processing equipment can not meet the specification requirements.
Liaoning province suspended the sale of 5 drugs. May 2nd, the Liaoning provincial food and Drug Administration issued a notice on the 5 kinds of serious violations of Chinese medicine products in Liaoning province to suspend sales. Someone’s business and products: Harbin family pharmaceutical production Xianling Dihuang Bushen Granule (Liaoning TV channel and television channel, broadcast 95 times), CHUANKENING tablets Changchun Xin’an pharmaceutical production (Liaoning TV channel, broadcast 15 times), the new Kunming Xuanju capsule bio pharmaceutical production (Liaoning TV channel broadcast, 14), Luo Huang tablets Liaoning PENGJian pharmaceutical production (Dalian evening news, new business, issued 5 times), Guiyuan Jiannao tablet Henan Kang Xin pharmaceutical production hundred years (evening newspaper, issued 1 times).
38 batches of substandard drugs were investigated, involving 36 batches of Chinese medicine. The day before, Shanxi province food and Drug Administration released drug quality announcement, make a random inspection by the province within the scope of the pharmaceutical production and operation enterprises and medical institutions, 38 batches of the drug is not in conformity with the provisions were found, including 21 batches of the non production or the enterprise production. In the 38 batch of drugs, traditional Chinese medicine products involving 12 batches of vinegar myrrh and myrrh 11 batches, 10 batches of safflower, Fructus aurantii Immaturus, dittany bark, dodder 1 batches.
-6 (August 4, 2017), the Chinese Academy of traditional Chinese medicine (TCM) hosted the 2017 China (Beijing) International Health Expo of traditional Chinese medicine and the first Forum on the development of traditional Chinese medicine health services. Address: China International Exhibition Center, contact person and telephone: Wan Xin 010-6556 7337.
[culture] week on October 21, 2017 -22, a World Federation hosted the Fourteenth World Congress of Chinese medicine and Chinese Medicine Culture Week area. Address: Thailand, Bangkok, contact person and telephone: Zou Jianhua 010-5865 0042\/5865 0243.
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