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The state intends to greatly increase the threshold of generic drugs. 80 % of the domestic generic drugs will disappear?
Release time: 2015-12-10 & nbsp & nbsp & nbsp Source: Anonymous
    Shanghai Pharmaceutical issued an announcement on the application for the unprepared application of the pharmaceutical registration application of the holding subsidiary,It is said that in the "Announcement on the Notice of 13 Drug Registration Applications for 14 Enterprises" issued by the State Administration of Food and Drugs on December 7,An Aspirin Smooth Piece Application Application for the Holding Subsida Changzhou Pharmaceutical Factory is not approved。
 
    With more than 200 drug registration applications Stake Sports Bettingstake online sports bettingfor withdrawal within a week
 
    According to the announcement,The State Food and Drug Administration conducted a clinical trial data on -site verification of some drug registration applications that have been submitted for self -examination,After the verification, there are 14 companies in 14 companies in 14 drugs.,According to relevant regulations, the 13 drug registration applications will not be approved。Shanghai Pharmaceutical Group Co., Ltd.'s subsidiary Changzhou Pharmaceutical Pharmaceutical Factory Co., Ltd.。Recently,Announcement such as Shanghai Pharmaceuticals, many listed companies have released,Among them, there are many big -name pharmaceutical companies。
 
    Mid -last month,The State Food and Drug Administration announced the "Opinions on the Evaluation of Consistent Evaluation of the Quality and Consistent Effects (Draft for Consultation)",Among them, it is clear that some generic drugs have completed consistency evaluation by the end of 2018,Approval number of those who fail to pass the drug。Some people in the industry pointed out,This will cause many domestic medicines to be unable to pass,Some people call this ratio or as high as 80%。
 
    ​​A fact is,On December 3rd, the State Food and Drug Administration released a "Announcement on the Application of 62 Enterprises withdrawing 87 Drug Registration",62 companies withdrew 87 drug registration applications。stake betting appThis stake betting appphenomenon is already the second time in a week,90 companies have withdrawn 164 drug registration applications。This week,The withdrawal rate of the application for drug registration has been close to 40 %,Most of them are generic drugs。
 
    A variety of domestic & ldquo; Popular drugs & rdquo;
 
    The so -called generic drug is relative to the original medicine。Original research drugs mainly refer to the original new drug products,Due to the particularity of the medicine,The emergence of new drugs must be approved by tens of thousands of compounds to screen and strict clinical trials.。Data show,The birth of a kind of original medicine takes about 15 years of research and development time and a total cost of up to hundreds of millions of dollars。This means,Often, only large multinational pharmaceutical companies have the ability to develop original research drugs,Therefore, most of the varieties in the pharmaceutical market in my country are the patents owned by foreign pharmaceutical factories.,That is the generic drug。
 
    For example, many Chinese people scramble to meet Haitao's medicines that treat gouty -not Tiss Pharmaceuticals were originally developed by the Japanese emperor、Produced by French Patheon Pharmaceutical Company,There was no such medicine in the Chinese market.,Many patients are purchased through Haitao,Even this kind of medicine once appeared stake betting appin the stake betting appHong Kong market。but,In 2013, the patent of the Japanese emperor's patent for this drug expired,Soon China Jiangsu Wanbang Pharmaceutical、Jiangsu Hengrui Pharmaceutical and Hangzhou Zhu Yangxin Pharmaceutical will begin to produce this medicine。On the Chinese pharmaceutical market,Similar to this kind of patent, the proportion of imitation drugs after expiration is very large。Data show,At present, more than 95%of the approval number of nearly 170,000 drugs in my country are generic drugs。
 
    A large number of generic drugs are hard to say
 
    The so -called & ldquo; consistency & rdquo; refers to the same quality and efficacy of imitation drugs and original drugs。But the facts,Imitation drugs and original drugs to achieve completely consistent is not easy,and the key is to see & ldquo; how to evaluate & rdquo;。It is reported,India, another major generician country in the world,Performators of human biological equivalent tests for generic drugs,But its pass rate is usually only 60%,Explain that the same quality and efficacy are not easy to imitate the same quality and efficacy.。
 
    A person familiar with the matter told the Beijing Youth Daily reporter,Imitation drugs do copy the main molecular composition of the original research medicine,But often contains different additives and internal component substances in the pharmaceutical composition,Therefore, it is difficult for generic drugs and original drugs Stake Sports Bettingto stake online sports bettinghave biological equivalent。However,How the real effect of a large number of generic drugs is difficult to say now。That is to say,How many Chinese generic drugs are being used in the future can pass or variables。