[Zhou Jun] on the first day of construction, every province raised a strict inspection: Guangdong regulated drug circulation, Hubei flying inspection retail drugstore

Key local news: Guangdong regulates drug circulation and focuses on drug traceability On February 22, Guangdong food and Drug Administration issued a notice requiring enterprises to rectify within a time limit or request the Provincial Bureau to cancel the certificate of quality management specification for drug trade or revoke the drug trade license if the review results do not conform to the drug trade quality management specification, and conduct on-site inspection if necessary The key point of this inspection is whether the drug wholesale enterprises take effective quality control measures in drug purchase, storage, sales, transportation and other links to ensure the quality of drugs, and establish a drug traceability system in accordance with the relevant national requirements to achieve drug traceability On February 22, the drug administration will focus on nine major problems of drugstores On February 22, the food and drug administration departments at the four levels of Hubei Province, city, district and street dispatched 13 law enforcement officers to jointly carry out "flight inspection" on retail drugstores It is understood that this joint flight inspection focuses on checking whether the license is complete, whether the drug purchase channel is legal, whether the purchase account is standardized, whether the pharmacist is on duty, and whether the prescription drug sales are standardized Looking at the latest inspection focus of drug administration, the following nine red lines can't be stepped on in 2018 1 Illegal sales of prescription drugs; 2 Licensed pharmacists hang licenses ; 3 Drug purchase; 4 Illegal drug sale on the Internet; 5 False drug sale; 6 Stealing and swiping medical insurance; 7 Illegal production and sale; 8 Drug management; 9 Out of scope and out of mode operation Five pharmacies in Changchun, Jilin were ordered to rectify On February 23, Changchun food and Drug Administration of Jilin Province issued the announcement of GSP certification information of Changchun drug handling enterprises (the fourth issue in 2018) According to the report, 41 drug handling enterprises, 36 drug handling enterprises including Jilin Guoying pharmacy chain Co., Ltd met the requirements of the regulations on quality management of drug management and passed the inspection 5 Pharmaceutical trading enterprises do not meet the requirements of the "pharmaceutical trading quality management standards" and are required to make rectification within a time limit 61 hospitals in Henan Province have the same catalogue of antibacterial drugs and 48 auxiliary drugs On February 22, Henan Medical Administration website published the antibacterial drug purchase catalogue of 61 hospitals, covering 21 provincial hospitals in Henan Province, such as Henan people's Hospital, the First Affiliated Hospital of Zhengzhou University, and 40 tertiary hospitals including Zhengzhou Central Hospital and Zhengzhou children's hospital On the same day, the website re linked the directory of auxiliary drugs of 21 hospitals and 9 counties in 18 cities of Henan Province, covering a total of 48 directories of auxiliary drugs published by various hospitals in all cities of Henan Province Data summary 2017 China drug R & D data summary Recently, the article "overview of China's drug research and development in 2017" written by Li Tianquan, co-founder of yaozhi.com, was recently published in the Journal of China's food and drug administration The main contents include: from the perspective of drug registration of domestic pharmaceutical enterprises in 2017, the number of chemical new drug applications decreased significantly, but the gold content increased, and the acceptance number of chemical 1 or 1.1 reached 324; new biological products There has been a lot of progress in drug registration In 2017, CDE undertook 66 class 1 biological products for treatment (based on the acceptance number), and the research and development of trastuzumab, bevacizumab and other similar biological drugs are still hot spots; the application for registration of traditional Chinese medicine is still severe, especially in the aspect of new drug registration, there are only 36 clinical applications, most of which are class 6 new drugs According to the drug approval of domestic pharmaceutical companies in the US FDA in 2017, there are 38 products declared according to the US FDA's short new drug application (anda), including 10 products of Huahai pharmaceutical As overseas listed varieties can enjoy the special policy of consistency evaluation when they are transferred to domestic application, in 2017, 7 varieties of Huahai pharmaceutical industry passed the consistency evaluation in China and became a big winner In 2017, the number of generic drugs approved by FDA broke the record In 2017, the U.S Office of generic drugs (OGD) approved 1027 generic drugs, becoming one of the FDA's records, which is 214 more than the record breaking 2016 Among them, 843 were officially approved and 184 were pre approved (i.e applications that were prepared for approval from a scientific point of view but could not be fully approved due to patent protection or exclusive nature of brand drugs) Among them, there are 80 generic drugs, that is, the first generic brand drugs Another 5 drugs passed the consistency evaluation Recently, CFDA released the second batch of reviewed drugs that passed the consistency evaluation, namely, risuvastatin calcium tablets (5mg, 10mg) of Zhejiang Jingxin Pharmaceutical Co., Ltd., tenofovir dipivoxil fumarate tablets of Qilu Pharmaceutical Co., Ltd., escitalopram oxalate tablets of Sichuan Kelun Pharmaceutical Co., Ltd., benzenesulfonic acid of Jiangsu Huanghe Pharmaceutical Co., Ltd Amlodipine tablets In addition to the 17 previously announced, 22 varieties have passed the consistency evaluation Enterprise hot 1.9 billion! Harbin Pharmaceutical received the global health products giant! Recently, Harbin Pharmaceutical announced that it will subscribe the convertible preferred shares issued by GNC of the United States for nearly 300 million US dollars (about 1.9 billion yuan), with the conversion price of 5.35 yuan / share At the same time, the annual dividend rate of the preferred shares is 6.5% GNC has the right to pay the preferred shares dividends in the form of cash or the issuance of preferred shares to Harbin pharmaceutical, including the combination of cash and the issuance of preferred shares After the completion of the investment, Harbin Pharmaceutical will become a major shareholder of GNC, holding about 40% of the common shares of GNC E-commerce giant Amazon sold medicine! The first batch of own varieties 60! Recently, according to media reports, Amazon has started to sell its own brand of over-the-counter drugs on the platform The brand of this series of over-the-counter drugs is "basiccare", similar to the over-the-counter drugs that consumers can buy through convenience stores, including anti allergy drugs and painkillers At present, the product scale of this brand is expanding, including about 60 products New technology & new viewpoint: Chinese research is listed on the cover of cell, which can accurately diagnose multiple diseases Recently, Professor Zhang Kang, a Chinese scholar, published his research in the latest issue of cell magazine What they bring is an artificial intelligence (AI) tool that can accurately diagnose multiple diseases At present, researchers have used choroidal neovascularization, diabetic macular edema, hyaline verruca, and normal OCT images to test this algorithm The overall accuracy of the AI tool has reached 96.6% In addition, they use the same deep learning framework to make accurate diagnosis of pneumonia in children Six policies impact many pharmaceutical companies In 2018, according to media analysis, the following six policies have great impact on pharmaceutical enterprises: 1 GMP and GSP certification are cancelled, and pharmaceutical enterprises are facing high-frequency supervision; 2 In the second half of 2018, the two vote system plays an important role; 3 Under the high pressure of environmental protection, small and medium-sized pharmaceutical enterprises are out of business; 4 Pharmaceutical enterprises go to sea, scale M & A; 5 Medical insurance reform, innovative drugs welcome unprecedented opportunities; 6 Drug collection enters a new era Content source: yaozhi.com, State Food and drug administration, Guangdong food and drug administration, academic editor, etc