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    Home > Active Ingredient News > Drugs Articles > Inventory from January to October 2018: review and approval data of domestic drugs

    Inventory from January to October 2018: review and approval data of domestic drugs

    • Last Update: 2018-11-23
    • Source: Internet
    • Author: User
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    Since 2015, a series of major domestic drug regulatory policies have been released intensively, and the pharmaceutical industry has changed a lot

    The most significant one is the review and approval of domestic drugs

    As 2018 is about to pass, the author makes an inventory of the review and approval of domestic drugs up to now

    In the first 10 months, 6111 drug acceptance numbers were accumulated from January to October 2018, and the total number of drug application acceptance numbers undertaken by CDE was 6111

    The total number of acceptance numbers in the first 10 months has exceeded the total number in 2017 and 2016

    Note: the acceptance number in 2018 is the statistical quantity of the first 10 months

    Among the 6111 drug application acceptance numbers, the number of chemical drug applications is 4820, which is the main category of domestic drug applications, accounting for 78.87%; the number of biological product applications is 740, accounting for 12.11%; the number of traditional Chinese medicine applications is 339, accounting for 5.55%; the number of class 1 new drug applications in a single month is kept in double digits, reaching 295

    According to statistics, there are 541 new drug approvals in total

    As of November 16, the Drug Administration approved 541 new drug approvals, including 455 domestic approvals and 86 import approvals

    Gastrointestinal medicine is the most approved field According to ATC classification system, the top 10 drugs with the number of approvals are digestive tract and metabolism (97), systemic anti infective drugs (87), nervous system drugs (75), anti-tumor drugs (62), respiratory system drugs (50), blood and hematopoietic organ drugs (47), cardiovascular system drugs (30), muscle bone drugs (21), skin diseases Drugs (21) and sensory organs (19)

    Among them, there are 97 approval documents for digestive tract and metabolic drugs, with the first number, continuing to lead the way since 2017

    In terms of specific categories, doxofylline injection received 10 approvals, ranking first, followed by rocuronium injection and esomeprazole sodium for injection, including 9 approvals for esomeprazole sodium for injection, 7 approvals for levocetirizine hydrochloride oral solution, flucloxacillin sodium for injection and cefdixone sodium for injection Wen

    The top 10 pharmaceutical companies with the highest number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number of number

    Since 2018, a number of heavyweight new drug varieties have been approved and listed in China, most of which are imported new drug varieties, and most of the indications are cancer, hepatitis and other clinically urgent varieties

    Among the domestic new drug varieties, Zhengda Tianqing, Hengrui medicine, Hutchison Whampoa and Geli pharmaceutical have all been approved as a class 1 new drug

    Among them, many new drugs have set a number of "first" records on the market, and these achievements are actually changes in drug review and approval in China

    Lvrtini, which was approved by Weicai pharmaceutical in September 2018, is the first product to submit listing application with international multi center test data and obtain the qualification of priority review and approval since the promulgation of the decision of the State Food and Drug Administration on adjusting the registration and management of imported drugs

    On April 20, 2018, the listing application of the nine valent human papillomavirus vaccine (Saccharomyces cerevisiae) of mosadong was accepted by CDE

    Within eight days, it was qualified to be approved for listing, and the review and approval time refreshed the listing record of new drugs in China.
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