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    Home > Medical News > Latest Medical News > [Medicine heaven and earth] focus on the problem of long-term biological vaccine. 20 provinces make a centralized voice and stop using it! Two provinces announced that the procurement was suspended! The prime minister spoke on vaccine yesterday

    [Medicine heaven and earth] focus on the problem of long-term biological vaccine. 20 provinces make a centralized voice and stop using it! Two provinces announced that the procurement was suspended! The prime minister spoke on vaccine yesterday

    • Last Update: 2018-07-24
    • Source: Internet
    • Author: User
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    Focus on 20 provinces to make a centralized voice and stop the long-term biological rabies vaccine Unqualified DPT vaccine flows to three places, and Shandong Province has identified the destination of the vaccine Public opinion on the issue of long-term vaccine continued to ferment, the prime minister said Premier Li Keqiang, the key information in the pharmaceutical industry this week, made a comment on the vaccine incident: a clear account must be given to the people of the whole country In his instructions, Li Keqiang asked the State Council to immediately send an investigation team to thoroughly investigate the whole process and chain of all vaccine production and sales and find out the truth as soon as possible No matter which enterprises and people are involved, they will resolutely punish and never tolerate We will resolutely crack down on all illegal and criminal acts that endanger people's lives and safety, severely punish the illegal elements in accordance with the law, and resolutely hold accountable for dereliction of duty and dereliction of duty We will return to the people a safe, secure and trustworthy living environment as soon as possible Prior to July 16, Li Keqiang had given instructions on the vaccine incident and asked for a thorough investigation 2 Unqualified pertussis vaccine flows to Shandong, Hebei and Chongqing Shandong has identified 252600 unqualified pertussis vaccines sold to Changchun Changsheng company to Shandong Province, accounting for 3.96% of the annual use of the province, and flows to 8 cities including Jinan, Zibo, Yantai, Jining, Tai'an, Weihai, Rizhao and Laiwu This batch of vaccines has been inoculated 247359, with 5241 lost and sealed, involving 215184 children The vaccination information of children has been registered in detail in the vaccination unit, and the flow direction has been fully identified, and no suspected abnormal reaction of vaccination has been found in the children involved At present, Shandong Provincial Center for Disease Control and Prevention said that in order to ensure that children who have been vaccinated with unqualified DPT vaccine are free from disease, Shandong Province uses qualified DPT vaccine to carry out routine vaccination of subsequent doses of DPT vaccine in accordance with national immunization procedures In addition to Changchun Changsheng, in November 2017, the State Food and drug administration also found that the titer test results of pertussis component in pertussis vaccine (batch No 201607050-2) produced by Wuhan biological company did not meet the registration standard A total of 400520 vaccines of this batch were sold to Chongqing centers for Disease Control and Prevention (CDC) in 190520 and Hebei centers for Disease Control and Prevention (CDC) in 210000 According to the CDC of Hebei Province, through careful verification, the problematic vaccines have flowed to Shijiazhuang, Langfang and Dingzhou, with 143941 people using substandard vaccines At the same time, Hebei disease control said that in order to ensure the health of children who have been inoculated with unqualified DPT vaccine, Hebei Province uses qualified DPT vaccine to carry out routine vaccination of subsequent doses of DPT vaccine according to the national immunization procedures Chongqing Health and Family Planning Commission also said in an open mailbox reply to a netizen's complaint that, according to the national unified deployment, Chongqing will make up for children vaccinated with unqualified DPT vaccine After organizing experts to discuss, we have completed the technical scheme of the supplementary seed training in the whole city At present, relevant preparations are being further improved and will be carried out simultaneously with Shandong and Hebei provinces involved Three or two provinces announced to suspend the purchase of long-term biological rabies vaccine Shaanxi public resources trading center issued the notice on suspending the purchase of freeze-dried human rabies vaccine of Changchun Changsheng Biotechnology Co., Ltd on July 16 The announcement clearly pointed out that the products involved: freeze-dried human rabies vaccine (Vero cell) (product specification: 0.5ml/dose after re dissolution, 5 doses / person), Pre filling) suspend the sale and use, and CDC at all levels shall carefully check the information related to the products according to the relevant notice of SFDA during the purchase and warehousing Hunan Public Resources Trading Center issued the notice on suspending the purchase of human rabies vaccine of Changchun Changsheng Biotechnology Co., Ltd (see the figure below for details of the notice) on July 20, and required all departments to do a good job in the emergency purchase and supply of rabies vaccine Photo source: the official website of Hunan Public Resources Trading Center (420 provinces) made a centralized voice and announced the discontinuation of Changchun Changsheng rabies vaccine Since July 16, many disease control departments have responded According to incomplete statistics from relevant media, as of July 22, at least 20 disease control departments of provinces, autonomous regions and municipalities directly under the central government had made a voice on Changchun Changsheng vaccine incident CDCs in Shanghai, Henan, Hainan, Chongqing, Shandong, Shanxi, Guangxi, Hebei and eight provinces and cities clearly stated that Changchun Changsheng rabies vaccine should be completely stopped or suspended; CDCs in Hunan, Fujian and Guangdong said that there were no batches of rabies vaccine involved in the province In addition, the disease control departments in Tibet, Beijing, Tianjin and Jiangxi said they did not purchase the rabies vaccine products of Changchun Changsheng company or the batches involved in the purchase As of July 22, many provinces and cities introduced the recall According to Henan Province, as of 12 noon on July 17th, the number of Changchun Changsheng rabies vaccines reported and sealed by Henan province is 141380.8 (5 for each person), which is estimated to account for more than 90% of the total market volume of Changchun Changsheng rabies vaccines in Henan province; according to Guangxi centers for Disease control and prevention, Changchun Changsheng company voluntarily recalled itself, which is a corporate behavior By July 18, 2018, Guangxi had 58 93384 rabies vaccines were recalled from counties (cities and districts), and the freeze-dried human rabies vaccine of Changchun Changsheng Biotechnology Co., Ltd was suspended and stored in place since July 15 in Chongqing At the same time, lots of vaccines related to long-term biological problems in many provinces have been sealed completely, and qualified vaccines from other manufacturers have been used for public vaccination Local pharmaceutical enterprise dynamics 1 strictly control the quality of Chinese herbal pieces, 3 pharmaceutical enterprises are accepted GMP Sichuan Zhongyong Pharmaceutical Co., Ltd has seriously violated the provisions of the drug production quality management specification, and the authorities decided to withdraw the GMP certificate in accordance with the law Guangxi jinhaitang Pharmaceutical Co., Ltd has committed illegal activities such as untrue production records, disordered production management, and inconsistent raw and auxiliary materials accounts and goods, and the Guangxi Zhuang Autonomous Region drug administration decided to withdraw the GMP certificate on July 16 Take back the GMP certificate of the enterprise In addition, Henan Provincial Food and Drug Administration issued a notice on July 16 on the withdrawal of the GMP certificate of Henan Zhongxin Pharmaceutical Co., Ltd (see Table 1 for details) table 1: spot check of local drugs related to the list of enterprises whose GMP certificate has been withdrawn by the local drug administration: on July 16, the 22nd batch of unqualified drugs was released by Jiangsu Provincial Drug Administration in the third phase of 2018, and a total of 22 batches of unqualified drugs were spot checked (see Table 2 for details) Among them, there are two batches of non-conforming chemical drugs, antibiotics, biochemical drugs and proprietary Chinese medicine, and 20 batches of non-conforming Chinese medicine and herbal pieces The second batch is not produced by the manufacturer Table 2 list II purchase of 22 batches of unqualified drugs: 10 drugs are suspended from online trading On July 18, Zhejiang Pharmaceutical Machinery Procurement Center issued a notice, according to the relevant provisions of the province's centralized drug procurement work, combined with the previous verification of the validity of the enterprise's GMP (GSP) certificate and the current supply and other conditions, through research, it was decided to suspend the online trading qualification of 10 products (see Table 3 for details) such as Naoan capsule from now on Table 3 price reduction in list 3 of 10 products suspended from purchase in Zhejiang Province: Hubei province takes the first shot in price reduction of anticancer drugs, and Shaanxi Province requires that 45 drugs (anticancer drugs, imported drugs) must be reduced On July 18, Hubei provincial public hospital drug (consumables) supply assurance comprehensive management network released the notice of Wuhan medical materials procurement management office on printing and distributing the 2018 work plan of price negotiation for some imported drugs of Wuhan medical institutions According to the announcement, 36 regulations (see Figure 2 for details), including 31 imported anticancer drugs, were included in the list of 103 imported anticancer drugs jointly released by multiple ministries and commissions Novartis, Pfizer, MSD, Sanofi, Lilly and other multinational pharmaceutical companies are among the list Photo source: comprehensive management network for drug (consumables) supply and security of public hospitals in Hubei Province On July 20, Shaanxi public resources trading center issued the notice on filling in the online price of anti-cancer drugs and imported drugs again The notice said that 45 drugs are required to fill in the online price again (see Table 4 for details) For the imported anti-cancer drugs with limited price calculated by the provincial procurement platform, it is necessary to re apply on the basis of no higher than the price limit, combined with the adjustment of zero tariff and value-added tax policies Offer a new price for the Internet; if there is no price reduction, a written explanation shall be submitted in real name on site For other imported drugs or domestic anti-cancer drugs declared in the centralized purchase of public hospitals, the new online price can be filled out voluntarily The new online price shall be lower than the limit price calculated on the basis of the national minimum 3 provincial average price and Shaanxi online price according to the relevant provisions of the "procurement document" Table 4 the local government of Shaanxi Province requests to fill in the list of 45 drugs with online price again, and proposes a new policy of "haotou" of 10 million yuan in Anhui Province to encourage the development of new drugs and generic drugs On July 18, the general office of the people's Government of Anhui Province issued "several policies to support the development of modern medical and pharmaceutical industries" to promote the high-quality development of modern medical and pharmaceutical industries Among them, the incentive policies for new drugs and generic drugs in the documents are as follows: for the major medical equipment projects such as the second development of new traditional Chinese medicine (1-4 categories) and classic Chinese medicine prescriptions, new chemical medicine (1-2 categories), biological products (1-5 categories) with new drug certificates, and medical devices of class III produced in our province, 20% of the development costs shall be subsidized for pre clinical research, and the development costs for clinical trials 10% of them will be subsidized, and the total amount of subsidy for a single project will be up to 10 million yuan; for each pharmaceutical enterprise that obtains the first copy (first copy) drug production approval document in China and settles in the province for production, a one-time reward of 2 million yuan will be given Second, Hubei Province opened the "green light" for 321 drug purchases On July 18, the comprehensive management network of drug (consumables) supply assurance of public hospitals in Hubei Province issued the notice on the implementation of the trial operation results of drug Qualification Access of public hospitals in Hubei Province According to the announcement, 321 drugs that will be selected into the directory of drug qualification and trial operation of public hospitals can be directly linked to the Internet in Hubei Province without bidding, and medical institutions should give priority to purchasing If there is a price limit on the Internet, the actual purchase price of the institution shall not be higher than the price limit on the Internet; if there is no price limit on the Internet, the price of similar products can be negotiated according to the market supply and demand 3 Beijing has established a monitoring system for the use of antimicrobial drugs, and clinical first-line doctors must "carefully prescribe Prescriptions" According to relevant media, Beijing will establish a monitoring system for the use of antimicrobial drugs in children's outpatient, emergency and inpatient departments All hospitals will strictly follow the requirements of varieties and product specifications to develop and improve the supply catalogue of antibacterial drugs The authority of antimicrobial prescription will be inclined to clinical first-line doctors The specific requirements are as follows: 1 The construction of diagnosis and treatment capacity of bacterial fungal infection should be included in the evaluation index of antimicrobial management 2 It is required that all hospitals should strictly follow the requirements of varieties and product specifications to formulate the supply catalogue of antibacterial drugs 3 The city will strictly implement the hierarchical management of antibacterial drugs and further standardize the use 4 Relevant departments have a comprehensive grasp of the clinical application and drug resistance of children's antimicrobial indicators 5 To strengthen the management of clinical application of antibiotics in elderly patients and pregnant women Information source: Elite Club of pharmaceutical intelligence, surging news, cypress blue, local medical station, Xinhua news agency, etc
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