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    Home > Active Ingredient News > Drugs Articles > What kind of native chicken will become Phoenix by consistency evaluation?

    What kind of native chicken will become Phoenix by consistency evaluation?

    • Last Update: 2015-11-27
    • Source: Internet
    • Author: User
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    Source: the opinions on the evaluation of quality and efficacy of generic drugs (Draft for comments) issued by CFDA on November 18, 2015 set a time limit for the completion of the consistency evaluation of domestic generic drugs, especially before October 1, 2007 (hereinafter referred to as "before 2008") )For the varieties of oral solid preparations of chemical generic drugs in the National Essential Drug Catalogue (2012 version) approved for listing, the consistency evaluation must be completed before the end of 2018, and if not, the approval number of the drugs will be cancelled directly For the varieties approved after October 1, 2007 (hereinafter referred to as "after 2008"), if the same varieties of other manufacturing enterprises fail to pass the evaluation within 3 years after the first varieties pass the consistency evaluation, the drug approval number shall be cancelled (will the first one complete the evaluation be hated by special recruiters?) The imperial edict has been issued, and the varieties approved after 2008 still have some breathing opportunities The varieties approved before 2008 can be said to be at the time of life and death How many varieties need to complete the consistency evaluation? Let's take a picture and feel it Note: the figure here refers to the variety and quantity of chemical oral solid preparations, excluding other dosage forms such as injections Before 2008, China approved a large quantity of domestic imitated drugs, with different quality The original intention of CFDA's consistency evaluation is to comprehensively improve the quality of domestic generic drugs, and hope that the general public's inherent impression of the failure of domestic drugs will be changed 20537 chemical oral solid preparations need to complete the consistency evaluation before 2018 How little do you think they can survive? Let's put a form for you to feel the lethality of the consistency evaluation of generic drugs Approval time: before 2008 and after 2008, compound sulfamethoxazole 10820, analgin 8990, vitamin C 789, norfloxacin 7850, metronidazole 7150, terramycin 7101, berberine hydrochloride 645, painless 6420 P-acetaminophen 639 12 amkahuang min 6051 rifampin 593 0 vitamin B1 587 0 chloramphenicol 559 0 Acetylspiramycin 541 0 erythromycin 538 0 inosine 526 0 vitamin B6 505 0 cimetidine 488 Ranitidine hydrochloride 4881 Cefalexin 4865 source: medicine magic cube database do we really need 789 enterprises to produce vitamin C oral solid preparations? Even if CFDA doesn't say clearly, are there enough resources for so many drugs and enterprises to complete the conformity assessment within three years? So, do you have a picture of corpses in front of you?
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