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    Home > Active Ingredient News > Drugs Articles > 2018 annual drug review report is released! Pay close attention to these key points

    2018 annual drug review report is released! Pay close attention to these key points

    • Last Update: 2019-07-05
    • Source: Internet
    • Author: User
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    [trends of pharmaceutical Station industry] how about drug evaluation in China in 2018? On July 2, the drug review center of the State Food and Drug Administration issued the 2018 drug review report The drug administration has carried out a series of work in encouraging drug innovation and research, improving drug quality and ensuring people's safe and effective access to drugs, continuously deepening the reform of drug review and approval system and ensuring public health According to the report, the author briefly combed out several key points According to the report of 47% increase in the acceptance of registration applications requiring technical review, in 2018, the drug Audit Center accepted 7336 new registration applications (calculated by acceptance number, the same below), including 5574 registration applications requiring technical review and 1762 registration applications requiring direct administrative approval (without technical review, the same below) Compared with 2017, in 2018, the acceptance volume of registration application tasks requiring technical review by the drug audit center increased significantly (47% higher than that in 2017) It can be seen that in 2018, the number of drug registration applications in China increased significantly, and the number of drug applications with high technology content also increased This also reflects from the side that in 2018, China's pharmaceutical market is more active, and the strength of pharmaceutical innovation and R & D is greatly improved In the future, there will be more high-quality new drugs that will benefit domestic patients and reduce their drug burden The acceptance volume of traditional Chinese medicine, chemical medicine and biological products has increased significantly Among the registration applications that need technical review by the drug review center in 2018, the acceptance volume of all kinds of drug registration applications for traditional Chinese medicine, chemical medicine and biological products has increased significantly, 30%, 50% and 42% respectively compared with 2017 There is a significant increase in the number of applications for registration of traditional Chinese medicine, chemical medicine and biological products, which also shows that the development prospects of these three fields are broad More and more enterprises are participating in the blue ocean competition in the market, and the enterprises with strength are actively taking the lead in the layout The number of clinical trials of domestic innovative drugs increased slightly According to the report, in 2018, the drug Audit Center accepted 448 applications for registration of domestic class 1 innovative drugs, involving 222 varieties Among them, 403 clinical applications (involving 198 varieties) and 45 listing applications (involving 24 varieties) were accepted According to the statistics of drug types, there are 323 chemical drugs (involving 115 varieties), 2 traditional Chinese medicines (involving 1 variety), 123 biological products (involving 106 varieties) The indications of innovative drugs are concentrated in the fields of anti-tumor, endocrine system and digestive system In 2017, the drug audit center received 402 domestic class 1 innovative drug registration applications (involving 181 varieties), including 379 clinical applications (involving 171 varieties) and 23 listing applications (involving 10 varieties) According to the statistics of drug types, there are 324 chemical drugs (involving 112 varieties), 2 traditional Chinese medicines (involving 1 variety), 76 biological products (involving 68 varieties) The indications of innovative drugs are mainly in the fields of anti-tumor and anti infection The indications of innovative drugs are mainly in the fields of anti-tumor and anti infection It can be seen that the number of domestic drug clinical trials accepted in 2018 increased slightly compared with that in 2017, the speed of acceptance also accelerated significantly, and the acceptance of biological products increased In addition, in terms of indications of innovative drugs, anti-tumor is still the focus area, but the endocrine system and digestive system are also becoming popular, while the proportion of anti infection field is decreasing The acceptance of imported drugs has been greatly reduced In terms of the acceptance of imported drugs, in 2018, the drug Audit Center accepted 75 applications for the registration of imported original research drugs of 5.1 chemical drugs, involving 50 varieties; and accepted 85 applications for the registration of imported innovative drugs of category 1, involving 42 varieties The indications of imported drugs are mainly in the fields of anti-tumor, circulatory system and digestive system   According to the 2017 report, in 2017, the drug examination center received 259 applications for registration of new imported drugs (involving 133 varieties), including 117 applications for registration of category 5.1 imported original research drugs (involving 70 varieties), 75 applications for registration of category 1 imported innovative drugs (involving 37 varieties), 67 clinical applications for international multi center imported drugs (involving 26 varieties) The indications of innovative drugs are mainly concentrated In the field of anti-tumor and anti infection It can be seen that the number of imported drugs has been greatly reduced, which is mainly affected by the rapid development of domestic innovative drugs and the domestic policies of starting volume procurement, medical insurance and fee control In terms of indications, the field of circulatory system and digestive system of imported drugs has become the focus.
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