[Mr. Zhou] many exclusive drugs will meet the market volume and increase in sales; Changchun 2 enterprises have exposed rabies vaccine problem; special fraud and deception action is rising nationwide; Yasheng pharmaceutical class 1 new drugs are recognized by the world

Pure dry cargo! 12 consistency evaluation guidance documents are coming For key words, please refer to November 23 CDE released 12 consistency evaluation guidance documents This is the result of the communication and exchange seminar between the consistency evaluation office, CDE and provincial bureaus All of them are dry goods Specifically, it includes the introduction of consistency evaluation work, variety compliance work, description writing and review, acceptance review work, production site inspection work, technical requirements and common problems, case analysis, experience sharing, be approval work, etc Want to see the details? Please pay attention to the official account of yaozh008, and reply to the document "4 + 7" urban drug centralized purchase rules released, 5 key points to know "4 + 7" urban drug centralized purchase and new trends! Following the official release of "4 + 7 urban drug centralized procurement document" last week, on November 21, the Shanghai Pharmaceutical centralized bidding procurement management office issued supplementary documents on the declaration of enterprises in Shanghai, drug distribution, quality inspection, tripartite agreement, payment for goods, use of selected varieties, etc The supplementary documents include: 1 Encourage the applicant to provide more than two weeks' dosage of chronic disease medication; 2 Only entrust one drug distribution enterprise with a selected variety; 3 The applicant must accept at least two sampling tests and necessary flight tests every year; 4 After signing the agreement five days later, the working organization shall pay 50% of the total payment to the distribution enterprise; 5 Continue to purchase and use the non selected drugs, but the number is The quantity shall not exceed the selected variety after being converted according to the proportion relationship Drug Administration issued a document: another injection, children should use it with caution on November 20 The State Drug Administration issued a notice that it will add warning words to the instruction manual of bromhexin hydrochloride injection (including bromhexin hydrochloride for injection, bromhexin hydrochloride injection, bromhexin hydrochloride glucose injection), and revise many items of [children's drug use] Among them, in the item of children's medication, it is indicated that "this test has not been carried out Children should use it with caution, especially not recommended for infants In terms of the revision frequency and strength of this year's drug instructions, the state has paid more attention to children's rational use of drugs, and has issued 24 revision announcements involving children's caution and prohibition, including multiple injections, mainly including Shenmai injection, Chaihu Injection, Danshen injection, Shuanghuanglian injection, Xueshuantong injection, Ciwujia injection Zushima injection The flu season is coming, and these drugs are endorsed by the state They will enter the peak season of sales According to the statistics of the number of influenza cases in 2017, the number of influenza cases has soared since October, and the number of influenza cases has been on the rise since October this year On November 20, the health and Health Commission issued the notice on printing and distributing the diagnosis and treatment plan for influenza (revised version in 2018) The Western medicines mentioned in the treatment plan include oseltamivir (capsules / granules), zanamivir and palamivir, and the traditional Chinese medicines include Jinhua Qinggan granules, Lianhua Qingwen capsules (granules), Qingkailing granules (capsules, soft capsules, tablets), Shufeng Jiedu capsules, Xiaoxiao Erdaiqiaoqingre granules, etc In the period of high incidence of influenza, the efficacy of treatment of influenza has been recognized by the state From the side, we can see that these drugs are about to usher in the situation of large market volume and rising sales Among them, oseltamivir (capsule / granule), Lianhua Qingwen capsule and Xiaoer douqiaoqingre granule are all star drugs in the field of influenza At present, only dongyangyao and Shanghai Zhongxi three-dimensional pharmaceutical industry have been approved to produce oseltamivir in China Lianhua Qingwen capsule (granule) and Xiaoer douqiaoqingre granule are the exclusive varieties of Yiling pharmaceutical industry and Jichuan pharmaceutical industry in Shijiazhuang respectively Fraud insurance special action is heating up again, 32 province report telephone is opened for the first time, what didn't find should be rechecked? On September 11, the National Health Insurance Bureau, together with the Health Commission, the Ministry of public security, the drug administration and other four departments, launched a nationwide special action to combat fraud and insurance fraud nationwide During the special action, the case of Shenyang insurance fraud was exposed by the CCTV focus interview This not only shows the necessity of special action, but also reflects that there are still many loopholes in the supervision of medical insurance fund On November 21, the state health insurance bureau held another special action conference to fight against fraud and insurance fraud, and carried out a nationwide "look back" special action, focusing on investigating and punishing medical institutions' behaviors such as obtaining medical insurance funds, falsely recording or recording more medical service fees For the first time, the special action of "looking back" has announced the telephone numbers of reporting and complaint in 32 provinces and cities nationwide, encouraging the masses and the society to report, and the telephone answering time is up to January 20, 2019 In addition, in January next year, the special leading group will select some local staff to carry out spot check and reexamination of "looking back" work in some provinces Provinces that have not found problems or major cases may be subject to spot check Changchun again! The re exposure of rabies vaccine resulted in the rejection of 100000 bottles of rabies vaccine for human use produced by the biopharmaceutical enterprise in Changchun after the event of long-term biological vaccine On November 21, CFDA announced that it would not issue the human rabies vaccine produced by the two enterprises, that is, the product could not obtain the marketing license, totaling about 100000 bottles, and the two enterprises are located in Changchun In the announcement, there are two products refused to be issued, one is called "human rabies vaccine (Vero cell)", and the batch issued quantity is 43500 bottles, which is produced by Jilin maifeng bio Pharmaceutical Co., Ltd Another product is called "freeze dried human rabies vaccine (Vero cell)", with a batch quantity of 57200 bottles, which is produced by Changchun Zhuoyi biology Co., Ltd Which is the best government subsidy? Step, Huahai, Lizhu In November, humanwell pharmaceutical, Lizhu pharmaceutical and Huahai pharmaceutical announced that they have received government subsidies Humanwell pharmaceutical announced that the company has received government subsidies of 90 million yuan Lizhu pharmaceutical announced that the company and its subsidiaries have received government subsidies of 268 million yuan since this year Huahai pharmaceutical also received government subsidies of 21 million yuan this month, plus all the companies and their subsidiaries previously announced by Huahai The subsidiary Huahai pharmaceutical received a total subsidy of 300 million yuan, totaling 321 million yuan When it comes to government subsidies, we have to provide step pharmaceutical So far in 2018, step has issued four government subsidies announcements, involving about 355 million yuan Fucking great! Yasheng pharmaceutical's class 1 new drug has been recognized in the world, and clinical research has entered the oral report of the top conference November 21 Yasheng pharmaceutical announced that a clinical study of the company's original class 1 new drug hqp1351 has been selected into the oral report of the 60th annual meeting of the American Society of Hematology (ash) It is reported that ash is the world's largest professional association on the cause and treatment of blood diseases The annual ash conference is the world's leading academic exchange event in the field of Hematology This year, it will be held in San Diego, the United States, from December 1 to 4 Hqp1351 is the third generation bcr-abl inhibitor, which is used to treat CML (chronic myeloid leukemia) resistant to Gleevec As of June 30, 2018, the preliminary clinical results of more than 60 CML resistant patients showed that hqp1351 had good clinical safety and effectiveness, suggesting that the drug has the potential to become the "best in class" original drug in the treatment of CML resistant to Gleevec worldwide What's the reason why Enhua pharmaceutical is full of children and grandchildren? This year, after the establishment of the wholly-owned subsidiary of Enhua bio and the holding subsidiary of Shanghai Enyuan bio, on November 19, Enhua pharmaceutical announced that it plans to establish a wholly-owned subsidiary of "Xuzhou Yihe Pharmaceutical Co., Ltd." with its own capital of 2 million yuan It is worth mentioning that one of the major businesses in the newly established business scope of Xuzhou Yihe pharmaceutical is "pharmaceutical intermediates R & D outsourcing service", while Enhua Pharmaceutical Co., Ltd This keyword has not been mentioned in the semi annual reports of 2017 and 2018 of pharmaceutical industry At present, there are more than 15 wholly-owned subsidiaries, holding subsidiaries and joint ventures of Enhua pharmaceutical In addition to the business throughout the pharmaceutical industry chain, there are two "Internet Medical" enterprises With such a wide range of businesses, is the Enhua pharmaceutical industry in the name of generic medicine "not doing business"? In response, media analysis said that Enhua's series of actions may be to resist the risks brought to enterprises by policies such as consistency evaluation Content source: State Food and drug administration, health industry, sapperland, first finance and economics, economic daily · China economic network, Beijing Youth Daily, Meitong news agency and other statements: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.