[week leader] talk about hot news of the week (June 27, 2016 to July 1, 2016)

In May 2016, FDA approved a total of 10 new drugs, including new indications, first approval, new compound and supplementary new drug applications The heaviest of these are oberlicholic acid and Tecentriq, the first PD-L1 inhibitor In May, EMA approved a total of 13 new drugs, including new indications, first approval, new compound and new combination therapy The heaviest of them are the neparvis heart failure drug and the first fabrician drug, galaford In June, all the new drugs approved by Japan were 5 new indications In June 2016, the bidding dynamics of drugs were summarized In June, the bidding dynamics of various provinces and cities were relatively frequent The pharmaceutical intelligence editor summarized the bidding dynamics of drugs in June for reference (as of June 29) The provinces and cities worthy of attention this month include Yunnan, Shanxi, Sichuan, etc On Yuheng Pharmaceutical (1) on May 31, 2016, Yuheng pharmaceutical announced that it planned to sell 100% equity of Pude pharmaceutical, and the buyer was Qianyuan pharmaceutical (2) On June 6, 2016, Yuheng pharmaceutical PD-1 monoclonal antibody was accepted by CDE (3) Ningbo Yudong Health Technology Co., Ltd., a joint venture company established with Jingdong, has an initial registered capital of 50 million yuan and a total investment amount of 1 billion yuan is expected to build a platform for chronic disease generic medicine business (4) The board of directors agrees that the company plans to use its own funds not more than US $85 million to invest in foreign high-quality medical and health products Shanghai Yuhan equity investment fund partnership was established Yuheng pharmaceutical is good at capital operation and seems to be relatively successful at present We can look forward to the result as to why we are keen to sell some overseas assets while we may make a profit of 200 million per year We should pay more attention to drug research and development, especially the big cake of biological drugs We should not be afraid that there are strong enemies in front of us and pursuers behind us From time to time to some high-quality agent varieties, such as last year's first three party Artem For Yuheng pharmaceutical, the current sodium creatine phosphate for injection has encountered a growth bottleneck when we sell Pude How can we make a breakthrough in recent performance? Let's watch as we go Is it a "helpless" or a "strategy" for the separation of departments of multinational pharmaceutical enterprises? In recent years, Department divestiture has become an important way for pharmaceutical companies, especially large multinational pharmaceutical companies to remove inefficient departments, exit non nuclear business, adjust strategies, get rid of financial difficulties, improve management and optimize organizational structure The so-called sector divestiture refers to a kind of business behavior that an enterprise sells its own sector to a third party to obtain cash or stock or a mixed form of cash and stock as return For example, Pfizer, Johnson & Johnson, Novartis and other famous companies have "streamlined" their business departments in recent years, and further "intensive cultivation" has been selected in their best fields In June 2016, new drugs were listed in the market In June, Europe and the United States, the big winner of new drugs approved by Gilead company was approved by three compound drugs For antiviral research, other manufacturers can only worship! The biggest gain in new indications is abbvie Xiumeile, the world's king of medicine, has obtained the 10th indication approval from FDA / EU and the approval of the indication of Crohn's disease in Japan The drug companies with one week's policy have been flying tested? On June 27, Fujian food and Drug Administration issued the notice on the implementation measures of Fujian food and drug flight inspection (for Trial Implementation), clearly proposing the following seven situations, which can be organized to carry out flight inspection: (1) complaints or other sources indicate that food and drug may have quality and safety risks; （2） It is found that there are quality and safety risks in food and drugs; (3) the monitoring of food safety risks, adverse drug reactions or adverse events of medical devices indicates that there may be quality and safety risks; (4) there is doubt about the authenticity of the application materials; (5) it is suspected of seriously violating the requirements of laws and regulations and quality management norms; （6） Where there are serious records of non-compliance; and (7) other circumstances requiring flight inspection Self inspection and verification come to this large number of pharmaceutical enterprises or stop production and receive certificates! On June 21-22, the State Food and Drug Administration held a consistency evaluation meeting in Beijing Wu Zhen, deputy director of the meeting, said that it was necessary to increase the verification of prescription and process changes As soon as the voice dropped, a notice entitled "notice on Further Strengthening the supervision of drug production process" began to circulate in the industry On March 22, 2016, the U.S Food and Drug Administration (FDA) issued a request to revise all product manuals containing opiates to include the following risk warnings: 1、 Opioids may interact with antidepressants and migraine drugs, leading to a severe central nervous system response known as serotonin syndrome 2、 The use of opioids can lead to a rare and serious adverse reaction in which the adrenal glands of patients do not produce enough corticosteroids 3、 Long term use of opioids may lead to the decrease of sex hormone level and sexual desire, impotence or infertility The specific scheme of 100 ° hot news consistency evaluation is coming Pharmaceutical companies want to take the lead in the layout Recently, a speech about consistency evaluation was said to be made by a director of Beijing Bureau at more than one meeting The whole speech content is classified into 15 items by netizens How to understand and use each item 1 Enterprises should choose and choose varieties 2 Enterprises need to carry out secondary development and systematic research on varieties 3 The reference preparation shall be put on record first, especially for those without suitable control drug, it shall also be reported as soon as possible The General Administration wants all enterprises to move quickly! 4 It is required by the General Administration of one-off import formalities that each provincial bureau shall be responsible for it On the issue of import clearance, Beijing Bureau may also be responsible for the clearance of neighboring provinces and cities 5 The reference drugs selected for the same variety may be different The filing of reference preparations shall be reviewed and demonstrated by experts of the consistency evaluation office, and can be carried out as long as they are approved All enterprises must seize the moment! 6 In vitro dissolution curve should be included in the quality standard and should be checked at any time Even if be is consistent, the four dissolution curves must be consistent 7 The chemical be filing is equivalent to a set of materials for registration, which can be completed only after the completion of production verification 8 At least 4 sets of data shall be prepared after be: 2 sets shall be submitted to the consistency evaluation office, 1 set shall be submitted to the drug inspection office 9 The varieties of exemption can be applied for first, and the State Bureau will issue the exemption catalogue in succession 10 After changing the prescription process, when will it be submitted to CDE? It has not been determined yet It is only after CDE agrees to change it? 11 For the clinical trials to be carried out, supplementary application can be made and the clinical approval documents can be obtained But the plan is still under discussion 12 So far, most of the policies for consistency evaluation have been clear, and all enterprises should move as soon as possible 13 All the test samples shall be kept by the hospital and shall not be returned to the sponsor for inspection at any time 14 Director Bi required that the data of conformity evaluation should be generated synchronously following the United States (Statistics) 15 Supplement: (1) policies such as compound preparation are needed; (2) the general administration requires all generic drugs to be evaluated for consistency, and the definition of generic drugs is classified according to the new registration classification; (3) pre be needs to be reported even if the result fails (this is Yao Chen's opinion); (4) pre be needs to be filed before implementation After the State Food and Drug Administration issued the announcement on rectifying the illegal business activities in the field of drug circulation (No 94 in 2016, hereinafter referred to as the announcement), the provincial food and drug regulatory departments immediately carried out the rectification actions according to the requirements of the announcement At present, the self-examination stage of drug wholesale enterprises has ended, and now the enterprise self-examination situation is announced The traditional Chinese medicine Liuwei Dihuang pill has 40 kinds of wonderful effects Although many people may think Liuwei Dihuang pill is said to be supernatural now, Liuwei Dihuang pill really has many effects! Today, Xiaobian summarized 40 kinds of efficacy of Liuwei Dihuang pill for you If you have similar symptoms, you can take Liuwei Dihuang pill Liuwei Dihuang pill is a representative prescription for nourishing yin and kidney, which is composed of six herbs, namely, prepared Dihuang, yam, Cornus officinalis, Alisma, Poria cocos and cortex moutan It is traditionally used to treat dizziness, weakness of waist and knee, tinnitus, spermatorrhea, hand, foot and heart heat caused by deficiency of kidney yin and deficiency of fire In recent years, through clinical observation, Liuwei Dihuang pill has been found to have many functions Liuwei Dihuang pill has significant effects on enhancing immunity, anti-aging, anti fatigue, anti hypothermia, anti hypoxia, reducing blood fat, blood pressure, blood sugar, improving renal function, promoting metabolism and strong strength The new contents of the meeting of the General Administration of drug conformity assessment exclusively revealed the work of drug conformity assessment for the first time, which has been affecting the hearts of tens of thousands of pharmaceutical enterprises Before that, the specific scheme of consistency evaluation of the general administration was circulated on the Internet, but there were many unscientific places Recently, a new version of consistency evaluation scheme 2.0 has been circulated on the Internet (details are as follows) Compared with the previous version, this version is more scientific and reasonable, and the specific measures need to be known before the policy is issued Such as walking on thin ice: more than 3000 GSP pharmacies have been cancelled, and more than 1000 have crossed the red line of flight inspection According to incomplete statistics, from January to June 2016, there were 1396 drug distributors ordered to rectify or file a case, 3003 drug distributors cancelled GSP, 183 drug distributors cancelled or recovered GSP Who will lose their jobs under the current new medical policy? In 2016, the hottest discussion was about the pharmaceutical industry, and the biggest worry was about the future of the pharmaceutical people, or even many people worried about no tomorrow! In order to improve the overall level of the pharmaceutical industry and ensure the safety and effectiveness of drugs, since the second half of last year, China has issued a series of relevant documents, promoted the reform of drug review and approval system "consistency evaluation", "two vote system" to optimize the order of drug purchase and sale, and compressed the circulation link Industry insiders believe that a series of "super drug" policies put forward new requirements for drug research and development, production and sales, which will inevitably lead to the reshuffle of the entire pharmaceutical industry Bi Jingquan: consistency evaluation is related to the life and death of pharmaceutical enterprises Backward production capacity should be eliminated! What is the purpose of consistency evaluation? Consistency evaluation, the most important thing is to complete the quality evaluation of drugs Once the quality evaluation of drugs is completed, the original drugs will be the biggest impact It is imperative to evaluate the consistency of generic drugs, and enterprises must choose between them The large-scale cleaning of document numbers has come, and there may be more than ten thousand document numbers will disappear Pharmaceutical Cleaning: research and development, production, circulation, terminal! Recently, the draft of the document that the State Food and drug administration plans to carry out self inspection and verification on the drug production process has been exposed In addition, the document No 94, which continues to be implemented until October, and the final version of the "two vote system" policy that is about to be implemented under the leadership of more than 10 ministries and commissions under the leadership of the national medical reform office in the middle of June All these indicate that: research and development, production, circulation and terminals are to be checked, and the whole industry chain of the pharmaceutical industry is to be checked Great renovation, inspection and cleaning have come! Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!