[one week Jun] after tax inspection, 21 pharmaceutical companies hit the gun again; new regulations were issued in the review of overseas new drugs; 7 years of cooperation between China Resources and Zhangzhou Pianzihuang was concluded; Huahai and Junshi worked together to develop Avastin

This week's highlights: 1 New cooperation mode to support the inheritance and development of traditional Chinese medicine; 2 The urgent need for overseas new drug review and further "drug standard review and inspection"; 3 For the regulatory vacuum zone, the Inspection Branch of Jilin Province was unveiled; 4 China Resources and Zhangzhou Pianzihuang planned to terminate the cooperation; 5 Tax inspection, 22 pharmaceutical enterprises hit the "muzzle" On June 27, the State Drug Administration, together with the Chinese Academy of traditional Chinese medicine and Beijing University of traditional Chinese medicine, signed a cooperation agreement on the scientific research of Chinese medicine regulation, and established the scientific research center of Chinese medicine regulation and the Scientific Research Institute of Chinese medicine regulation This scientific research cooperation on Chinese medicine supervision is a strategic measure taken by the State Food and drug administration, the Chinese Academy of traditional Chinese medicine and the Beijing University of traditional Chinese medicine to implement the central government's requirements on strengthening drug supervision and deepen cooperation between the two sides It is also a practical action to carry out education on the theme of "never forget your original mind and keep your mission in mind" Its purpose is to further promote the scientific development of the supervision of traditional Chinese medicine from a political point of view, and effectively guarantee the safety, quality and efficacy of traditional Chinese medicine; thoroughly implement the relevant laws and regulations of traditional Chinese medicine, improve the safety management system of traditional Chinese medicine, and promote the development of the rule of law and standardization of traditional Chinese medicine supervision; strengthen the theoretical and practical innovation of traditional Chinese medicine supervision, and build a combination of traditional Chinese medicine theory, human experience and clinical research A comprehensive evidence evaluation system for registration and evaluation of traditional Chinese medicine, a scientific standard system for traditional Chinese medicine and a post market regulatory system should be established to promote the supervision of traditional Chinese medicine to a new level Urgent need for overseas new drug review and further "drug standard review and inspection" On June 25, the State Food and Drug Administration issued a notice saying that in order to implement the requirements of the notice on issues related to the review and approval of clinically urgently needed overseas new drugs (No 79, 2018), accelerate the review and approval of clinically urgently needed overseas new drugs, it has organized and formulated the requirements for materials and samples (chemicals) for the reexamination and test of clinically urgently needed overseas new drug standards and the reexamination of clinically urgently needed overseas new drug standards Data and sample requirements for nuclear inspection (biological products) It is mentioned in the announcement that for the varieties listed in the list of clinically urgent overseas new drugs published by the drug evaluation center of the State Food and drug administration, the applicant shall submit relevant materials and samples for drug standard review and inspection to CFDA at the same time when applying for drug listing according to the requirements of the announcement The key words of "centralized purchase" and "drug price" are widely heard in the industry On June 25, the centralized purchase network of Hebei Province released the news that as for the suppliers of fosinopril sodium tablets, due to the lack of BMS capacity, they could not meet the purchase demand of Hebei Province, and they openly selected new manufacturers that could meet the purchase standard to supply On June 26, the next day, Hebei provincial medicine centralized purchase network announced that, after negotiation and consultation between the two sides, Huahai Pharmaceutical Co., Ltd and fosinopril sodium tablets of the same specification were able to select the middle price of national centralized purchase in Hebei Province and have the supply capacity This also means that in 2018, 60% of the use of fosinopril sodium tablets (10mg * 14 tablets) in Hebei was successfully taken by Huahai At the same time, Hebei officially announced its entry into the bureau to follow up the national volume procurement On the same day, the notice on inviting the state to centrally purchase the selected drugs with the same generic name and the notice on inviting the state to centrally purchase the selected drugs with the same generic name and the notice on confirming the online price with the state to centrally purchase the selected drugs with the same generic name was released, which clearly indicated that Hebei would follow up the implementation of the national drug centralized purchase on July 1 From the current trend, it can be seen that although the second batch of national drug centralized procurement program has not officially fallen, all regions and enterprises have already been unable to sit down The key directions of the national pharmaceutical industry can also be divided into "centralized procurement" and "drug price" On June 26, the national health and Health Commission held a press conference on typical experience of comprehensive medical reform pilot provinces in Tongling, Anhui Province When it comes to solving the problem of "expensive medical treatment", it puts forward to further reduce the virtual high drug price Each pilot province actively implements the national basic drug system, centralized procurement and other reform measures to squeeze out the water of the virtual high drug price As Fujian, Qinghai, Shandong, Jiangxi, Henan, Inner Mongolia and other places issued statistical statements and follow-up documents, many provinces and cities have officially started to follow up the national centralized mining or are preparing to follow up the national centralized mining, and in the near future can see the obvious expansion trend In addition, Huadong pharmaceutical's acarbose chewable tablets have applied for independent price reduction in Heilongjiang, Hainan and Guizhou, and the price of lenalidomide, a popular anticancer drug, has been reduced recently No doubt, they are telling us that the policies of drug centralized purchase continue to be promoted or brewing, and drug companies are also making independent price cuts to varying degrees The market competition under the general trend will undoubtedly be more intense And this also releases a signal that the centralized procurement of all regions may soon be implemented Under this trend, how to seize the market in advance by pharmaceutical enterprises needs to pay close attention to the centralized procurement trend of all regions and put it on the agenda Aiming at the regulatory vacuum zone, Jilin Provincial Inspection Branch was unveiled at 10:00 a.m on June 13, and "Changchun Inspection Branch of Jilin Provincial Drug Administration" was unveiled, which opened the prelude to the official listing and performance of duties of all inspection branches of Jilin provincial drug administration As of June 18, 9 municipal (prefecture) inspection bureaus of Jilin provincial drug administration have been listed, and the reform of drug safety supervision system in Jilin Province has made substantive and critical steps, which is of milestone significance for ensuring drug safety, promoting the development of pharmaceutical industry and benefiting the people's livelihood Since November 14, 2018, Jilin provincial drug administration has been officially established, and no independent drug regulatory department will be set up below the provincial level In order to prevent the occurrence of regulatory vacuum zone, Jilin Province immediately started to promote the implementation of the province's drug regulatory system institutional reform, establish a special working mechanism, and comprehensively promote the establishment of Inspection Branch This is undoubtedly a new attempt to the drug market This undoubtedly requires the staff to perform their duties and work hard, strengthen daily supervision and flight inspection in an all-round way, thoroughly check and rectify the potential risks, urge the enterprise to consciously implement the quality management standards of drug production and operation, and eliminate the problems and potential risks in the bud in time A strong industry needs strict supervision, which makes a strong industry Up to now, the reform of Jilin provincial drug administration system has completed many tasks, such as setting posts and personnel, setting up vaccine inspection center, and setting up municipal (prefecture) inspection branches, which has laid a solid organizational foundation for strengthening drug safety supervision in an all-round way I believe that in the future practice process, it will certainly bring inspiration to other provinces and cities, make drug manufacturers more standardized, more standardized, and make the Chinese drug market more modern Enterprise information tax inspection, 21 drug companies hit the gun! On June 28, the local medical station learned from the State Administration of taxation that 21 pharmaceutical enterprises were notified in the published information on major tax violations in April 2019 13 of them are pharmaceutical production and marketing enterprises Among them, 18 pharmaceutical companies are suspected of "falsely issuing special VAT invoices or other invoices used to defraud export tax rebates and offset taxes" Shanghai jiangcai Pharmaceutical Technology Co., Ltd and Guangxi Liuzhou Wuda Pharmaceutical Co., Ltd were notified by the State Administration of Taxation for "tax evasion"; Guangzhou Suoyue Medical Equipment Co., Ltd., Shenzhen jinguangyuan Biotechnology Co., Ltd., Shenzhen huaxuanbiaosheng Pharmaceutical Co., Ltd and Shenzhen Gankang Pharmaceutical Co., Ltd were fined; while other 17 pharmaceutical enterprises were all fined for the amount involved in the case In addition to being fined, the relevant person in charge is also punished by the decision of transferring to the judicial organ At present, the State Administration of Taxation has notified the above-mentioned enterprises and their relevant persons in charge to collect taxes and fines according to law, transfer them to judicial organs according to law, etc Huahai and Junshi jointly develop Avastin On June 25, Huahai pharmaceutical announced that Shanghai huaaotai biopharmaceutical Co., Ltd (hereinafter referred to as "Shanghai huaaotai"), a holding subsidiary of the company, and Shanghai Junshi Biopharmaceutical Technology Co., Ltd (hereinafter referred to as "Junshi bio") signed the drug technology transfer and cooperative development contract on June 24, 2019 Huahai Pharmaceutical Co., Ltd and Junshi biological Co., Ltd have made relevant agreements on the follow-up R & D, production, marketing and sales cooperation of Avastin monoclonal antibody biological similar drug (project code "hot-1010") and the joint application cooperation of hot-1010 and Junshi biological treprizumab injection With respect to the existing research and development achievements of hot-1010 transferred by Shanghai huaaotai and its follow-up technical support, Jushi biological has agreed to pay a total of 90 million yuan to it in three phases China Resources and Zhangzhou Pianzihuang plan to terminate cooperation According to the information publicized by Shanghai United Property Rights Exchange, China Resources pharmaceutical is listed to transfer 51% of the equity of China Resources Pianzihuang Pharmaceutical Co., Ltd That is to say, the situation of cooperation for seven years, with the right of equity transfer now, the cooperation may also end In 2012, China Resources pharmaceutical signed a contract with Zhangzhou pianzehuang Both parties will jointly contribute to the establishment of China Resources Pianzihuang Pharmaceutical Co., Ltd Zhangzhou pianzehuang injects 7 products (Xinshubao tablet, compound pianzehuang buccal tablet, yindanpinggan capsule, Hugan tablet, compound pianzehuang ointment, compound pianzehuang hemorrhoids ointment, pianzehuang runlaryngosaccharide) into the joint venture as part of the investment, and will sign an exclusive distribution agreement with the joint venture China Resources Pharmaceutical Group has introduced its marketing management platform and channels to jointly build the integration of R & D, production and marketing based on the series of products and other new products This also means that after the completion of the transfer, China Resources film Zihuang and its subsidiaries will no longer be able to use "film Zihuang", "pientze Huang" and the related brand names as their names, brand names, trade names or publicity purposes, unless otherwise agreed in writing by Zhangzhou film Zihuang Pharmaceutical Co., Ltd And this time, Zhangzhou Pianzihuang will inevitably lose the commercial channel resources of China Resources pharmaceutical Information source: yaozhi.com, enterprise announcement, CDE, cypress blue, Sina medicine, local medicine Station, health information bureau 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.