The evaluation of injection consistency was accelerated, and the battlefield of 4 + 7 was once again tragic. According to the national general office, the shortage of drugs could increase the price reasonably; the audit of scientific and technological innovation board was accelerated; Ma stepped on the territory, pointed to the world, and expanded the territory step by step

This week's highlights: 1 Accelerated evaluation of injection consistency, 4 + 7 battlefield again tragic; 2 The national general office said: shortage of drugs can reasonably increase the price; 3 Accelerated review of science and technology innovation board listing! But does going public necessarily mean success? 4 The horse steps on the territory, the heart points to the world, and the step size expands the territory The evaluation of the consistency of injections in the important news of the general administration was accelerated, and the 4 + 7 battlefield was tragic On October 15, in order to promote the consistency evaluation of quality and efficacy of chemical injection generic drugs, the official website of the State Food and Drug Administration successively issued the technical requirements for consistency evaluation of quality and efficacy of chemical injection generic drugs (Draft for comments) (hereinafter referred to as the technical requirements) and the application data requirements for consistency evaluation of quality and efficacy of chemical injection generic drugs on the market (Draft for comments) (hereinafter referred to as "requirements for application materials") are two documents, which are open to the public for comments With the improvement of injection consistency evaluation measures, the process of injection consistency evaluation will continue to speed up, and the 100 billion injection market will usher in a big reshuffle In terms of specific data, there are 12 new acceptance numbers (10 varieties) of CDE in this week alone, among which 6 varieties are injections, accounting for 50% This also marks the official opening of the injection consistency evaluation war and the acceleration of the injection consistency evaluation At the same time, after the National Bureau issued a document to open the injection consistency evaluation, the national procurement competition in the era of 4 + 7 will be more intense, involving more varieties, involving more enterprises, and the adjustment, transformation and upgrading of enterprise strategy has become more and more urgent! In 2018, the annual report of adverse reactions was released, and the supervision was strict to promote the steady development of society Recently, the drug evaluation center of the State Drug Administration issued the annual report of national drug adverse reactions monitoring (2018), which comprehensively summarized and analyzed the annual report of adverse reactions and events In 2018, 33 public notices on the revision of drug instructions were issued, 17 more than those in 2017 In addition, the production and marketing of thiol injection, terphene pseudoephedrine tablets, sulfasopyrimidine tablets and Trojan pseudoephedrine capsules were stopped Compared with 2017, the number of reports received by the national ADR monitoring network increased by 70000 to 1499000 in 2018, and the number of reports continued to increase The number of new and serious ADR / event reports received in 2018 was 495000, an increase of 62000 compared with 2017 In 2018, the overall adverse reaction rate of traditional Chinese medicine intravenous injection decreased, and the oral route increased With the continuous enhancement of patients' health awareness, the improvement of professional quality and infusion risk awareness of medical staff, the situation of traditional Chinese medicine infusion was controlled, and the data of adverse reactions was significantly reduced Finally, in 2018, a large number of drugs were modified and written off According to the comprehensive analysis, in 2018, the incidence of adverse reactions has indeed been well controlled, which may come from the introduction of various national documents On the one hand, the supervision of pharmaceutical manufacturers has been strengthened, and on the other hand, the use of drug users has been restricted This is evidence of the necessity of strengthening national drug supervision Three departments unite to make special rectification! On October 17, the Supreme People's Procuratorate, the State Administration of market supervision and the State Drug Administration jointly announced the implementation of the "four strictest" requirements for food and drug safety In order to promote the establishment of a safe food and drug environment, the Supreme People's Procuratorate, the State Administration of market supervision and the State Drug Administration decided to jointly carry out special actions to implement the "four strictest" requirements nationwide from September 2019 to December 2020 Wu Liya, deputy director of the policy and regulation department of the State Food and drug administration, said, "in the special action, the drug administration will strengthen the supervision of blood products, high-risk medical devices and other key products, and crack down on illegal and criminal acts." We will strengthen the supervision of high-risk products Strengthen the flight inspection and overseas on-site inspection, and strengthen the supervision of blood products, special drugs and other key products included in the national centralized procurement pilot varieties of drugs, high-risk medical devices, poisons and anesthetics Highlight the pertinence and targeting, increase the sampling of key varieties, improve the ADR system and the monitoring mechanism of adverse events of medical devices, strengthen the comprehensive application of monitoring results, strengthen the revision of instructions, and explore and improve the market withdrawal mechanism of varieties We will crack down on illegal and criminal acts in the field of drugs In addition, the recent relevant laws have further increased the punishment of illegal acts in the field of food and drug safety Procuratorial organs should actively promote the implementation of relevant laws, at the same time, they should also play the role of penalty according to law, and increase the cost of illegal crimes According to the National General Office of industry news, on October 14, Guizhou medicine centralized purchase platform issued the notice on the independent quotation of drugs in the list of short drugs in Guizhou Province (the second batch) (hereinafter referred to as the notice) The "list of short drugs in Guizhou Province (the second batch)" includes 38 short drugs Compared with the previous online prices, the prices of these 38 short drugs have increased to varying degrees Take nitroglycerin as an example For the purchase of 0.5mg * 100 bottles of nitroglycerin, the price quoted by some enterprises is 159 yuan For the first 100 bottles of nitroglycerin produced by Shandong Xinyi pharmaceutical factory, the price of the first bottle is 4.5 yuan, while the general price of the drug before was basically maintained at 30-40 yuan In 2015, nitroglycerin appeared in Jiangsu Province low price drug catalogue (2015 version), which was regarded as low price drug From the end of 2018 to the beginning of 2019, media began to report that nitroglycerin was in short supply in many places due to the lack of API supply In view of the problem of the rising price of the medicine in short supply, some comments pointed out that, as the standard drug for glaucoma surgery in the domestic eye field, the demand of Mitomycin for injection is only 30000 bottles a year If the price of Mitomycin for injection remains the same, the medicine will basically disappear It shows that market regulation is to some extent to allow the price of the drug to rise If we discuss the main reasons for the shortage of drugs, on the one hand, the monopoly of APIs, rising prices, high environmental protection costs, labor costs, packaging costs, transportation costs, etc.; on the other hand, the low bid prices of these drugs in the past have made it difficult for enterprises to cover the costs and have to choose to stop production or even withdraw from the market Therefore, recently, the general office of the State Council issued the opinions of the general office of the State Council on further ensuring the supply and price stability of drugs in short supply, which once again focused on the problem of drugs in short supply In addition to cracking down on the monopoly of APIs, liberalizing the approval documents of APIs, strengthening the monitoring of shortage drugs and improving the distribution system, respecting the reasonable profit demand of pharmaceutical enterprises may also be an important part of ensuring the supply of shortage drugs Speed up the examination and approval of the listing of science and technology innovation board! But does going public necessarily mean success? In the next week, Jiangsu shuoshi Biotechnology Co., Ltd., Zhejiang Dongfang gene biological products Co., Ltd., Shanghai Fudan Zhangjiang biomedical Co., Ltd., Wuhan Keqian biological Co., Ltd and other four pharmaceutical enterprises will be reviewed by the Municipal Committee of science and technology innovation board Recently, the listing of science and technology innovation board has become a major investment choice for potential enterprises However, as an enterprise, it is suffering from the lack of capital to have heavy products To some extent, the acceleration of the listing of science and technology innovation board is good news for them But on the other hand, the blowout of R & D will surely bring many enterprises the idea of "taking a wave of money and leaving" Moreover, in most cases, the market will never be short of potential products, just like the characters in martial arts novels, no matter how high the root bone is, there are many cases that can not go far That is to say, even if the science and technology innovation board is listed, it doesn't necessarily mean success With the improvement of investors' eyes, the requirements for listed enterprises may also be improved Not every enterprise can become a "micro core" A medical representative committed suicide because of the pressure from the society According to Indian media, a medical representative committed suicide on July 7 because of his colleague relationship The incident sparked concern in India's pharmaceutical industry, with relatives of the dead accusing local police in Bangalore that the representative committed suicide because he was harassed by the manager of his pharmaceutical company The 32-year-old medical representative, allegedly associated with Vimal pharmaceuticals, hanged himself on the ceiling fan after being accused by the company's director of embezzling 950000 rupees (about 95000 RMB) Although there is no final result of this month's incident in India, compared with other professions, it is an indisputable fact that most of the medical representatives bear more pressure in many aspects, because they have to deal with more interpersonal relations and work affairs in daily life In the past few years, similar events have occurred in China, some because of indicator pressure, some because of colleague relationship On a closer look, the medical representatives are not accepted by the public, many practitioners are even shy to talk about their own career Compared with the professional situation in the United States and other developed countries, the medical representatives in many countries with irregular medical environment are indeed day by day If we think about it, the medical representatives actually help doctors to use drugs and patients to save costs to a great extent The main reason why the medical representatives are not accepted by the public in China is that the lack of professional literacy and professional behavior of the medical representatives have a great degree of economic impact, resulting in the embarrassing situation today At the same time, similar events also remind the society that standardizing the professional quality of medicine and correcting the professional status of medicine have become the first thing in the circle In this way, more similar things can be avoided It's necessary for enterprises to have a sense of information defense Recently, Merck pharma and Pfizer have been quarreling about business secrets Merck Pharma made an insider public Merck stated that one of its former senior employees had jumped to Pfizer with a large number of business secrets, which increased the advantage of unfair competition for Pfizer The senior employee, Wendy Watson, was the regulatory liaison between MSD and the US FDA for vaccines She left MSD in 2011, but it was not until 2017 that MSD was informed of the alleged theft of R & D secrets It is suspected that Watson "secretly stole some very valuable information" during his resignation Merck sued Pfizer and Dr Watson for stealing "thousands of proprietary documents" from Merck and bringing them to new employers However, Pfizer, the new employer, said that MSD did not provide sufficient evidence to support the lawsuit, and there was no evidence that Pfizer knew or should have known about the alleged theft Faced with Pfizer's response, MSD said that its competitors "mistakenly described" the concept of trade secrets in front of the public and responded to the lawsuit with "false words" In view of this, it's hard for outsiders to know the details of the event, but the act of stealing other people's patents is also common in various industries In recent years, under the situation of global gold digging for star products, stealing the trade secrets of the best-selling drugs / R & D giants has become a hot topic in the pharmaceutical field But it also indicates the importance of protecting the core secrets of the enterprise, especially the R & D patents that cost a lot of money In today's market environment with such a large flow of enterprise personnel, the heart of human defense is indeed indispensable As for how to operate it, it's also a door to a certain extent