[yizhoujun] the 11 city volume purchasing catalogue has come, with 33 varieties in total; 3 drugs passed and 8 drugs will pass the consistency evaluation

Last week, new progress was made in the pilot joint procurement of drugs led by the state health insurance bureau The first batch of on volume procurement catalogue was published, including 33 varieties, including montmorillonite powder and cefuroxime ester tablets, which have passed the consistency evaluation by three enterprises; the first three varieties of Jiangsu Hengrui, Harbin Sanlian and Chongqing shenghuaxi passed the consistency evaluation; 15 varieties have priority evaluation, and 8 or will pass the consistency evaluation quickly Consequent evaluation 11 city drug pilot joint procurement to start! The first batch, 33 varieties! On September 11, the pilot joint procurement of drugs led by the state health insurance bureau held a symposium in Shanghai, at which the requirements and detailed rules of the joint procurement were introduced, and the first batch of volume procurement catalogue was published, with 33 varieties, including montmorillonite powder and cefuroxime tablets which have passed the consistency evaluation by three enterprises According to the previously circulated procurement plan, Beijing, Shanghai and Tianjin will be the 11th cities to purchase this time Starting from the selection of pilot varieties of generic drugs corresponding to generic drugs through the consistency evaluation of quality and efficacy (including deemed), the state organizes the pilot of centralized drug procurement The successful bidder will obtain 60% - 70% of the total annual drug consumption of all public medical institutions in the pilot area It is newly learned that the pilot area will appoint representatives to form a joint procurement office (hereinafter referred to as joint procurement) as the working organization to implement centralized procurement on behalf of the public medical institutions in the pilot area, and the daily work and specific implementation will be undertaken by Shanghai Pharmaceutical centralized bidding procurement management office In addition, the pilot centralized mining will be officially launched at the end of October and the beginning of November this year This round of national centralized mining will be carried out in the pilot area for 12 months After the completion of the evaluation and summary, it may be implemented nationwide National Medical Insurance Bureau, National Drug Administration, national health and Health Commission three plans out! Recently, the three fixed (functional allocation, internal organization and staffing) plans of the State Medical Security Bureau, the State Drug Administration, the State Administration of market supervision, the State Drug Administration and the state health and Health Commission have been circulated in the industry, and the documents all indicate "public release", which also officially discloses the specific post functions of each department Among them, the state health insurance bureau is mainly responsible for establishing a market-oriented price mechanism for social medical services; the State Food and drug administration is mainly responsible for improving the evaluation, inspection, inspection and monitoring system; the health care Commission is mainly responsible for deepening the reform of the medical and health system State Food and Drug Administration: it is agreed to add 2 authorized issuers of biological product batch issuance certificate documents of China National Drug Administration on September 11, and the drug administration announced that it is agreed to request for instructions on adjusting authorized signers of biological product batch issuance certificate documents of China National Drug Administration (ZJG [2018] No 11) It is agreed to add Zhang Zhijun (vice president) and Xu Miao (deputy director of the Institute of biological products inspection) as the authorized signer of the certificate of batch issuance of biological products Wang Youchun will no longer be the issuer of the certificate for batch issuance of biological products The State Food and Drug Administration will verify the 50 drugs on September 12, and the drug audit and inspection center of the State Food and Drug Administration issued a notice, which will carry out on-site verification of 50 drug clinical trial data self-examination verification varieties, such as compound reserpine aminophenetidine capsule The publicity period is 10 working days, from September 12, 2018 to September 26, 2018 A total of 50 drugs were inspected this time, among which 4 were in the foreign enterprise's product specifications, and the rest 46 were all domestic varieties, such as gefitinib tablets of Zhengda Tianqing, apixaban tablets and alisentan tablets, fosapintan and meglumine for injection of Jiangsu Haosen, pramipexole hydrochloride tablets and olanzapine tablets of Qilu pharmaceutical, gefitinib tablets of Hengrui, etc The collection report of individual adverse reactions will have guiding principles Recently, the State Food and Drug Administration issued guidelines for collection and reporting of individual adverse drug reactions (Draft for comments) The draft for comments made it clear that individual adverse drug reactions refer to the adverse reactions of individual patients when using drugs In marketing activities, such as patient support projects, market research, patient education and other activities, if individual adverse reactions are found Shall, shall collect and report as required The first three varieties of Jiangsu Hengrui, Harbin Sanlian and Chongqing shenghuaxi passed the consistency evaluation by 13 days, with 348 acceptance numbers of CDE acceptance consistency evaluation and 66 acceptance numbers This week (September 6 to September 13), 9 new acceptance numbers of conformity assessment were added, involving 6 products of 6 enterprises Among them, there are 2 varieties in 289 catalogue, including lamivudine tablets of Hunan qianjinxiangjiang Pharmaceutical Co., Ltd and kangkelglimepiride tablets of Chongqing; the first two that have been applied for acceptance are mecobalamin injection for injection of Shenzhen seaside Pharmaceutical Co., Ltd of Nanjing Hailing Pharmaceutical Co., Ltd of Yangtze River, south of meropenem In addition, Jiangsu Hengrui's tamsulosin hydrochloride sustained-release capsule, Harbin Sanlian pharmaceutical mirtazapine tablet, Chongqing Shenghua Xi pharmaceutical's zuoetiracetam oral solution passed the consistency evaluation, and got the top of the consistency evaluation (for more detailed analysis of the consistency evaluation varieties involved in this week, please click "good drug record") 15 varieties have priority review, 8 of which will pass the consistency evaluation quickly On September 11, the drug review center of the State Food and Drug Administration announced the 32nd batch of the list of priority review to be included In this batch, there are 15 acceptance numbers to be included in the priority review, 5 new drugs to be listed and 9 generic drugs to be listed, 11 of which are products of state-owned enterprises, involving Tianshi, hausen, Hengrui, Kelun, Qilu, Dongguang, etc In the generic drug market, four varieties of linagliptin tablets, linagliptin metformin tablets, pemetrexed disodium for injection of Qilu pharmaceutical and irinotecan hydrochloride injection of Huiyu pharmaceutical are produced in the same production line, and the foreign listed varieties are transferred to domestic approval; risuvastatin calcium tablets of Hefei Yingtai and aoyanping tablets of Chengdu Yuandong are voluntarily withdrawn by the applicant and changed into The application shall be re filed after the standards consistent with the quality and efficacy of the original research drug are improved; the first application shall be the cetifloxacin tablets of Shenzhen xinlitai Pharmaceutical Co., Ltd and the vadenafil hydrochloride tablets of Sichuan Kelun According to relevant policies, after the above 8 varieties pass the priority review and approval, they can be regarded as passing the consistency evaluation On September 13, the State Food and Drug Administration issued the catalogue of the 17th batch of generic reference preparations, with a total of 32 specifications Novartis' carbamazepine tablets (delido), Sino American Shike's Ibuprofen Sustained Release Capsules (fenbide), Bayer's aluminum magnesium carbonate tablets (Daxi), GSK's adefovir dipivoxil tablets (heveli) and other varieties are also listed as reference preparations as the original research and localization varieties Before the deadline, the National Bureau issued a total of 1129 product specifications for 17 batches of reference preparation catalogue State Bureau of market vigilance: 45 vaccine companies were screened No problems were found From July 23 to August 9, the State Food and Drug Administration sent 45 inspection teams to carry out comprehensive and thorough risk screening for 45 vaccine manufacturers (excluding Changchun Changsheng Biotechnology Co., Ltd.) in China According to the judgment standard of GMP, the investigation results show that the production of vaccine varieties in the existing enterprises is normal, and no problems affecting the quality and safety of vaccines are found at present 15 batches of unqualified drugs notified by the State Food and Drug Administration Recently, the State Food and Drug Administration issued a circular announcing that 15 batches of unqualified drugs, including 1 batch of cetirizine hydrochloride tablets marked as produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd., were found to be unqualified in dissolution; 3 batches of Paclitaxel injection marked as produced by Hainan zhuotai Pharmaceutical Co., Ltd and Sichuan Taiji Pharmaceutical Co., Ltd of Taiji group were found to be foreign matters For the above-mentioned non-conforming drugs, the relevant drug supervision and administration departments have taken control measures such as sealing up and detaining, requiring the enterprises to suspend the sale and use of the products, recall the products, and make rectification Alihealth officially announced the use of drug traceability code on September 12 Alihealth pharmacy announced the use of drug regulatory code Consumers can check the drug traceability code before placing an order After receiving the goods, they can compare the traceability code on the drug box and the order to ensure the safety of drug circulation At the same time, Ali Health announced its "super pharmacy 1.0" standard, namely the six operation processes of "global search, big data selection, spot check and review, all-round monitoring, drug traceability and all-weather service of licensed pharmacists" Step, the largest holder of traditional Chinese medicine injection Market in the company's dynamic, "transfer" biopharmaceutical industry 10 days ago, step pharmaceutical released the announcement on the company's biopharmaceutical strategic planning, announcing that it will strive to build the whole biopharmaceutical industry chain through the model of building platform, attracting talents and seeking cooperation, and transform from a localized enterprise to a global enterprise According to the announcement, at present, StepStep has made public investment of 1.72 billion yuan in biopharmaceuticals, and there are 10 kinds of biopharmaceuticals under research It is estimated that the earliest time to market is 2021, and the latest is 2029 2 billion 100 million! Merger and acquisition of well-known pharmaceutical companies, slam the brakes! On September 13, Hainan Haiyao announced that it would terminate the subject assets as a major asset restructuring of Haikou Qili pharmaceutical According to previous announcements, Hainan Haiyao plans to acquire 100% equity of Qili pharmaceutical in the form of cash transaction of 2.14 billion yuan According to the announcement, the reason for termination is that, in view of the great changes in the M & a market of the pharmaceutical industry in the near future, the company and the counterparty did not reach a final agreement on the valuation of the target company, which is not conducive to the promotion of this transaction In order to effectively protect the interests of listed companies and small and medium shareholders, the company decided to terminate this major asset restructuring Source: State Food and drug administration, Cyprian blue, e drug manager, pharmaceutical cloud studio and other statements: this point of view only represents the author, not the position of pharmaceutical intelligence network, 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.