[Zhou Jun] Bi Jingquan resigns; 18 kinds of anticancer drugs are included in the special negotiation of medical insurance admittance; no longer purchase without consistency evaluation

Last week, the vaccine incident was screened again, but the main role of the screen is no longer the leadership of Changchun Changsheng, but Bi Jingquan, Secretary of the Party group and deputy director of the General Administration of market supervision, and director of the former food and drug administration In the accountability of Changchun Changsheng vaccine case, Bi Jingquan was asked to resign and his friends were in a uproar Let's have a look: on August 16, the Standing Committee of the Political Bureau of the CPC Central Committee held a meeting to listen to the investigation and accountability of Jilin Changchun Changsheng vaccine case It was agreed at the meeting that Bi Jingquan (secretary of the Party group and deputy director of the State Administration of market supervision, former director of the State Food and Drug Administration from February 2015 to March 2018) should be asked to resign; Jiao Hong (director of the State Food and Drug Administration) should be asked to make an in-depth inspection; and Wu Zhen (former deputy director of the State Food and Drug Administration and former deputy director of the health and Family Planning Commission) should be appointed by the State Commission for Discipline Inspection and be in charge of the drug registration Physical and chemical supervision, audit and inspection, etc.) Where is Bijing spring going? Article 59 of the regulations on the selection and appointment of leading cadres of the party and government stipulates that: "the leading cadres of the party and government who resign, are ordered to resign and are removed due to accountability shall not be assigned any post within one year and shall not hold any post higher than the original post level within two years At the same time, the punishment of Party discipline and political discipline shall be carried out in accordance with the provisions of the period of influence " According to media reports, an administrative law expert who didn't want to be named suggested that for Bi Jingquan, "taking the blame and Resigning" is not an administrative sanction in a strict sense, but rather, in some form, leaving the original post and retaining its administrative rank while canceling the post A year later, will Bi Jingquan return to leadership? Let's see! From January 2015 to March 2018, Bi Jingquan served as the director of the State Food and Drug Administration and Secretary of the Party group During this period, he carried out a number of reform actions, including: 1 Self inspection of clinical trials 2 Clear up the backlog of drug registration applications 3 Conduct flight inspection 4 Promote innovation in drug and medical device reviews On August 18, 2015, opinions on the reform of the review and approval system for pharmaceutical and medical devices was released The key points are: (1) reform the clinical trial management to ensure the clinical trial is scientific, standardized and true; (2) speed up the market review of drugs and medical devices urgently needed in clinical practice to solve the public drug demand; (3) encourage innovation to promote the healthy development of China's pharmaceutical industry; (4) fully implement the listing license holder system and strengthen the whole life cycle management of medical devices 5 On March 5, 2016, opinions on the evaluation of quality and efficacy consistency of generic drugs was released 6 Towards internationalization In June 2016, CFDA was approved by the State Council to join the International Conference for the technical coordination of human drug registration (ICH) After the end of the game, where is the way to worry about medicine from the industry? As a pharmaceutical researcher, Biju has given our small and medium-sized enterprises the impetus to survive and innovate, thinking that we have seen the spring This vaccine incident doesn't mean that the administrative resignation of several leaders is the end of the matter We need to consider the long-term development plan It's heartbreaking I don't know where to go for our medicine? How does pharmaceutical innovation last? So many local pharmaceutical innovation projects are still in the cultivation period, so many venture capital investment has thrown money into the field of pharmaceutical innovation, if the process of approval standards and processes to international integration is backward, many projects will be scrapped What's more, China's pharmaceutical innovation ecosystem may soon collapse Supervision is strictly held accountable What should we do next? For problematic vaccines, if the drug regulatory officials should have found them but failed to find them, or if they have not reported them after finding them, they should share the responsibility with the enterprises However, if the drug regulatory officials are all conscientious, 24-hour staring at an enterprise, if the enterprise is still subjective fraud, defenseless, exhausted, and finally the drug regulatory officials will be held accountable, for the latter, if you predict the future results of this position, who will be loyal to this regulatory post? The hot spot of pharmaceutical purchasing has been determined! On August 17, the 18 anticancer drugs were included in the medical insurance negotiation, the National Health Insurance Bureau issued the notice on Issuing the scope of drugs for special negotiation on medical insurance access of anticancer drugs in 2018, confirming that 18 varieties of 12 enterprises were included in the scope of special negotiation on medical insurance access of anticancer drugs Among these 18 varieties, there are 16 varieties from foreign enterprises, among which, Novartis has 4 varieties: lucotinib phosphate, nilotinib capsule, pezopari tablet and serenitinib capsule; Pfizer has 3 varieties, namely, acitininib tablet, kezotini capsule and sunitinib malate capsule There are two varieties of domestic enterprises, including Zhengda Tianqing's enrotinib hydrochloride capsule and Hengrui's peimendong enzyme injection Weigh! On September 13, the national drug purchase pilot was launched, and the National Health Insurance Bureau met again to discuss the detailed rules for centralized drug purchase The medical insurance bureau plans to officially start the centralized procurement in the pilot cities in September, and it is expected to end this round of procurement in October and publish the relevant results It is understood that the national health insurance bureau is promoting the pilot drug procurement at the national level, involving 11 cities including Beijing, Shanghai, Tianjin, Chongqing, Shenyang, Dalian, Guangzhou, Shenzhen, Xiamen, Chengdu and Xi'an In terms of procurement scope: mainly starting from the selection of pilot varieties of generic drugs corresponding to generic drugs through consistency evaluation In terms of procurement mode: national organizations, public medical institutions in alliance areas are the main body of centralized procurement Among them, the most noteworthy is the procurement rules: for the three or more shortlisted production enterprises, bidding procurement shall be adopted; for the two shortlisted production enterprises, bargaining procurement shall be adopted; for the one shortlisted production enterprise, negotiation procurement shall be adopted Linking method of quantity and price: 60% - 70% of the total annual drug consumption of all public medical institutions in the pilot area is estimated to purchase Without conformity evaluation, the two pharmaceutical companies were suspended from purchasing their products Recently, Jiangxi pharmaceutical procurement service platform issued a notice on prolonging the procurement cycle of "two envelope" bid winning results and online procurement of generic drugs through conformity evaluation The notice clearly pointed out that for three products that have passed the conformity evaluation, the online procurement qualification of products failing to pass the conformity evaluation will be suspended, and the dynamics of products failing to pass the conformity evaluation will not be accepted Additional application The announcement also announced the suspension of online purchasing qualification for two drugs, namely, montmorillonite powder of Shandong Xianhe Pharmaceutical Co., Ltd and tenofovir dipivoxil fumarate tablets of Anhui Baker biopharmaceutical Co., Ltd the reasons for the announcement are: the above products failed to pass the consistency evaluation, and three other enterprises have passed the consistency evaluation, so the online purchasing qualification was suspended In the progress of conformity assessment, 16 varieties have been accepted and 7 have been declared for the first time; 2 varieties have been approved for the first time; 1 variety has been sent, and as of August 16, CDE has undertaken 309 acceptance numbers of conformity assessment, involving 126 varieties of 127 enterprises; 64 acceptance numbers have passed This week (August 9 to August 16), 22 new acceptance numbers were added, involving 16 varieties of 15 enterprises Among them, 7 varieties were declared for the first time, namely aripiprazole orally disintegrating tablets, vitamin B6 tablets, carbofenone acetate for injection, trimetazidine hydrochloride tablets, glucosamine hydrochloride capsules, ciprofloxacin hydrochloride tablets, ondansetron hydrochloride tablets; there are also 3 289 catalogue varieties listed, including captopril tablets, montmorillonite and acyclovir tablets In addition, fluoxetine hydrochloride capsule of Shanghai Pharmaceutical and glimepiride tablet of Guangzhou Hairui Pharmaceutical Co., Ltd of Yangtze River passed the consistency evaluation, and the evaluation status of cefuroxime ester tablet of Zhuhai federal pharmaceutical was updated to "issued" If there is no accident, it will become the third through enterprise (for more detailed analysis of consistency evaluation varieties involved in this week, please click to see "good medicine record") on August 13, 2014, the National Pharmacopoeia Committee announced that there are 40 new varieties to be added to pharmacopoeia biological products of 2020 edition of China Pharmacopoeia The publicity period is three months from the date of Internet access Specifically, it includes 40 new varieties of recombinant hepatitis E vaccine (E.coli), freeze-dried human rabies vaccine (human diploid cells), yellow fever attenuated live vaccine and Sabin strain polio inactivated vaccine Zhejiang medicine successfully defended in the United States, and the national API was exempted from tariff on August 14 According to the wechat official account "Shaoxing business" of Shaoxing Municipal Bureau of Commerce, Zhejiang medicine successfully excluded its export products from the list of 34 billion US dollars worth of commodities with 25% tariff added through the public review process At the same time, due to the defense of Zhejiang medicine, all the products of China's fine chemicals, APIs and preparations export enterprises have been exempted from tariff To this end, Zhejiang Pharmaceutical secretary office confirmed the matter to the reporter of "daily economic news" and said that most of the company's export products now win by price advantage This time obtaining the US tariff exemption helps to maintain the international competitiveness of the company's export products On August 15, the company's parent company, 111 group, submitted a prospectus to the securities and Exchange Commission of the United States with a maximum of $200 million, trading code of Yi, underwriters of JPMorgan Chase, Citigroup and CICC At present, 1 medicine network covers hundreds of thousands of medical and health products, such as Chinese and Western medicine, tonic and health care, medical devices, cosmetics and personal care Drug network 1 not only has a team of pharmacists to provide online medication consultation services for customers, but also provides online consultation, electronic prescription list and other services for customers with the help of "1 consultation" doctor team In terms of performance, 111 group's prospectus shows that the company's revenue in 2017 was 959.5 million yuan, and its revenue in the first half of 2018 was 730.9 million yuan In 2017, the net loss was 249.3 million yuan, and in the first half of 2018, the net loss was 129.5 million yuan On August 13, the Intellectual Property Office declared that the compound patent of Pfizer tofacitinib city (xeljanz) with the publication number of cn1409712a was all invalid Topaz is the first JAK inhibitor approved by FDA for the treatment of rheumatoid arthritis (RA), with global sales of US $1.345 billion in 2017 Up to now, more than 30 domestic pharmaceutical companies have applied for the generic drugs of the drug, and from the time of review and approval, it is Zhengda Tianqing that the preparation products may be approved as early as possible If Pfizer does not file a lawsuit, it is likely that cftb will be the first one to be listed before 2020 The official account is: the official website of the State Administration of drug administration, xinhuanet.com, health healthpoint public address, Wall Street news, daily economic news, etc.