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    Home > Medical News > Latest Medical News > The "immunoglobulin" incident is the latest, and Shanghai Xinxing has stopped production in an all-round way; another province forbids the contracted lease of pharmacies; three places encourage the research and development of generic drugs

    The "immunoglobulin" incident is the latest, and Shanghai Xinxing has stopped production in an all-round way; another province forbids the contracted lease of pharmacies; three places encourage the research and development of generic drugs

    • Last Update: 2019-02-12
    • Source: Internet
    • Author: User
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    At the beginning of the new year, local governments encouraged the research and development of generic drugs and generic drugs in three places, which has always been the key projects encouraged by provinces and cities Cash subsidies in the early stage and policy support in the later stage have accelerated the consistency evaluation of generic drugs In January 2019, Anhui, Sichuan and Guizhou provinces successively issued papers to encourage the research and development of generic drugs Among them, Anhui province encourages the creation of new drugs and the research and development of generic drugs, and improves the protection of drug intellectual property rights For the pharmaceutical enterprises that have obtained the first approval document of generic drug production in China and settled in Anhui Province, a one-off reward of 2 million yuan will be given; Sichuan Province requires to ensure that the generic drugs approved for listing are equally included in the payment scope of medical insurance, and the corporate income tax will be levied at a reduced rate of 15% for the generic drug enterprises that meet the preferential policies of western development or high-tech enterprises; Guizhou Province for the R & D and production of generic drugs And the enterprises that carry out the consistency evaluation of quality and efficacy of generic drugs will give preferential support to the construction fund arrangement of projects such as technological transformation and capacity expansion, variety technology innovation, comprehensive utilization of resources, energy conservation and emission reduction, and also require that the evaluated drugs be included in the procurement catalogue in time to promote the alternative use of generic drugs In addition, the provinces that have announced awards and subsidies are as follows: Ningxia will provide 2 million yuan for each variety that has passed the consistency evaluation, and 10% of the award and subsidy funds can be allocated in advance for those who have entered the consistency evaluation process of generic drugs; Fujian Province will give a one-time reward and compensation to the varieties that have completed the consistency evaluation by the end of 2018 according to the proportion of 20% of the evaluation cost and the maximum is no more than 1 million yuan; Anhui Province will give a one-time reward and compensation of 1 million yuan to each variety of generic drugs that have completed the consistency evaluation of quality and efficacy, and a single enterprise can get a maximum of 3 million yuan; Beijing plans to support 1-2 million yuan in science and technology for varieties that carry out in vitro consistency evaluation research, 2-3 million yuan in science and technology for varieties that carry out be test, 4 million yuan for single variety that has been evaluated in Shandong Province, 3 million yuan for each variety that has passed the national evaluation in Gansu Province, 3 million yuan for single drug that has been evaluated in Zhejiang Province; Jiangxi awarded 500000-1 million yuan to the varieties passing the evaluation; Sichuan awarded 1.5-2 million yuan to the top three varieties passing the consistency evaluation in principle; Zhejiang Province awarded 3 million yuan to the top three pharmaceutical manufacturers passing the consistency evaluation of generic drugs in a lump sum; For the top three enterprises that have passed the consistency evaluation and those that have passed the evaluation on schedule in Henan Province, One million yuan will be awarded in one time by the provincial finance; another two million yuan will be awarded in one time for each approval document of Chongqing city for those passing the consistency evaluation and ranking in the top three of the same varieties in China; the lowest 500000 yuan and the highest 4 million yuan will be awarded in Guangxi for those passing the consistency evaluation of generic drugs; Guizhou Province will provide more than 1 million yuan of project funds to each drug manufacturer that has passed the consistency evaluation Hunan Province will launch the pilot work of traditional Chinese medicine formula granules in 2019 According to the information from the Department of industry and information technology of Hunan Province on February 11, the traditional Chinese medicine industry is one of the important contents of the health industry and an important entry point to promote the integration of primary, secondary and tertiary industries In 2018, there were 372 large-scale enterprises in Hunan traditional Chinese medicine industry chain, with the main business income of RMB 57.13 billion, up 10.7% year on year At the same time, relevant departments announced that the work focus in 2019 includes the following three aspects: first, focusing on docking To organize and hold the cooperation and docking meeting of traditional Chinese medicine industry in Hunan Province, and promote the integration and development of essential resources of traditional Chinese medicine industry chain Second, promote incremental growth In conjunction with relevant departments such as science and technology and drug administration, we will push forward the pilot work of dispensing granules of traditional Chinese medicine, do a good job in coordinating services for key parks, enterprises and projects of traditional Chinese medicine, and accelerate the cultivation of new economic growth points of traditional Chinese medicine Third, improve the quality Strengthen the communication and connection with China 500 power Pharmaceutical Group, coordinate and promote the strategic layout of China traditional Chinese medicine company in Hunan, guide and support the cooperation between the upstream, middle and downstream enterprises of traditional Chinese medicine in the province and state-owned enterprises such as Sinopharm group, and improve the development quality level of traditional Chinese medicine industry Hebei issued a document forbidding public hospital pharmacies to lease Today, according to the Hebei provincial health and Health Commission, the provincial health and Health Commission and the provincial administration of traditional Chinese medicine have issued the implementation opinions on accelerating the high-quality development of pharmaceutical services, which clearly put forward that in order to ensure the quality and safety of pharmaceutical services, the health and health administration departments at all levels should strengthen the construction and management of pharmaceutical departments in medical institutions, adhere to the public welfare of public hospital pharmacies, and prohibit Public hospitals contract, lease or entrust pharmacies to for-profit enterprises We should rely on the pharmaceutical quality control center and other organizations to carry out the prescription review in the region and across medical institutions, incorporate the review results into the performance evaluation indicators of medical institutions, and link with the doctor's prescription right granting, professional title evaluation, regular assessment of doctors and the pharmacist's review of prescription quality evaluation At the same time, we should strengthen the monitoring, evaluation and abnormal early warning of clinical drug use, and monitor, analyze and evaluate the safety, effectiveness and economy of clinical drug use Industry hot news Shanghai emerging issue immunoglobulin event welcomes all parties to respond to SFDA: On February 6, 2019, the State Food and Drug Administration announced the preliminary investigation of emerging related products in Shanghai: the nucleic acid test of HIV, hepatitis B and C carried out by Shanghai for the involved batches of intravenous injection of human immunoglobulin was negative; the nucleic acid test of HIV in Jiangxi was negative National Health and Health Commission: on February 6, 2019, the national health and Health Commission issued the response to the relevant issues of "injecting human immunoglobulin HIV antibody positive": it has sent a working group to the local for guidance at the first time, and convened experts to analyze and judge the relevant issues According to the relevant international literature reports, combined with the characteristics of the production process of inactivated virus and the pH value of the product and other factors, experts believe that the risk of HIV infection in patients using the drug is very low Shanghai food and Drug Administration: on the evening of February 6, the Shanghai Drug Administration issued a circular saying that the Shanghai municipal Party committee and the Shanghai municipal government attached great importance to this matter and demanded that the work of drug removal and storage be carried out immediately, the facts be found out as soon as possible, the drug management be strengthened and the safety of drug use be ensured At the same time, Shanghai drug regulatory department immediately organized law enforcement personnel and experts to enter the production site, carried out investigation and disposal, controlled all relevant production and inspection records of the enterprise, sampled and submitted products for inspection, and required the enterprise to stop production and start emergency recall The municipal health and Health Commission has informed the medical institutions of the city to suspend the use of relevant products Beijing health and Health Commission: on February 6, according to relevant media, Beijing health and Health Commission has received relevant notice However, Beijing's human immunoglobulin is managed by reference to the vaccine and purchased by the municipal CDC The immunoglobulin products of the enterprise have never been purchased Shaanxi health and Health Commission: On February 5, the office of Shaanxi Provincial Health Committee issued a notice saying that according to the notice on suspending the use of Shanghai Xinxing Pharmaceutical Co., Ltd for intravenous injection of human immunoglobulin with relevant batch number issued by the national health and Health Committee, we are now making an emergency notice on relevant work, requiring the medical institutions within the jurisdiction to immediately suspend the use of Shanghai Xinxing pharmaceutical production batch number 20180610z for intravenous injection of human immunoglobulin Globulin At the same time, it is also required that the medical institutions that purchase the products with the problem batch number monitor the patients who have used the products with the problem batch number, closely observe the change of the condition, and require the health and health departments at all levels to conduct investigation and statistics on the use of the products with the problem batch number in the medical institutions under their jurisdiction Sinopharm: on February 11, Sinopharm issued a notice explaining the suspension of new batch drugs in Shanghai In terms of Shanghai Xinxing, the company informed relevant units to stop selling, using, sealing and recalling the batch of products in question at the first time when it learned that some products had problems, and at the same time, it also carried out a comprehensive check on the use of the batch of products in question; Shanghai Xinxing stopped production in an all-round way, and comprehensively checked the source of raw materials, production and quality control process of the batch of products in question Possible problems in the link Once any violation is found, the company will seriously investigate the responsibility of relevant personnel In addition, China Pharmaceutical set up a special working group to immediately enter Shanghai Xinxing, understand the specific situation and carry out on-site supervision In the announcement issued by China pharmaceutical, Shanghai Xinxing disclosed the main product income of Shanghai Xinxing from January to September 2018, in which the income from intravenous injection of human immunoglobulin was 56.1754 million yuan, accounting for 36.76% of the total income of main products However, due to the small proportion of emerging business scale and profits in China's pharmaceutical industry, the impact on it is small Photo source: enterprise announcement information source: yaozhi.com, sepilan, local health and Health Commission, enterprise announcement, China finance and economics 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; 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