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    Home > Active Ingredient News > Drugs Articles > Bi Jingquan: China's drug review and approval system reform has achieved remarkable results, basically eliminating the backlog of drug registration applications

    Bi Jingquan: China's drug review and approval system reform has achieved remarkable results, basically eliminating the backlog of drug registration applications

    • Last Update: 2017-06-23
    • Source: Internet
    • Author: User
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    Source: Dandelion 2017-06-23 Xinhua news agency, Beijing, June 22 (reporter Hu Zhe) on June 22, Bi Jingquan, director of the State Food and drug administration, was entrusted by the State Council to report to the Standing Committee of the National People's Congress on drug administration At present, China has basically eliminated the backlog of drug registration applications, and the number of drug registration applications waiting for review has dropped from 22000 at the peak in 2015 to 6000 The application for clinical trials of chemical drugs and vaccines and various registration applications of traditional Chinese medicine have been reviewed according to the time limit Bi Jingquan introduced that in order to solve the long-standing problems such as overstock of drug registration, slow listing of new drugs, low-level duplication of the pharmaceutical industry, and lack of innovation ability, the State Council issued the opinions on reforming the review and approval system of pharmaceutical and medical devices in August 2015, and the reform progressed smoothly: a batch of new drugs in China were approved for listing preferentially A priority review system has been established, and a number of "global new" drugs have been approved for clinical use, such as the recombinant Ebola virus vaccine, the third generation of drug-resistant mutant small cell lung cancer drug, ivetinib maleate, etc.; a number of innovative drugs and clinically urgent drugs have been approved for marketing, such as nanofloxacin malate capsule, oxitinib tablet, polio inactivated vaccine, EV71 vaccine, etc In February 2016, the general office of the State Council issued the opinions on the evaluation of the quality and efficacy of generic drugs, which clearly defined the objectives, tasks and incentive policies for the consistency evaluation of the marketed oral generic drugs according to the standards consistent with the quality and efficacy of the original research drugs At present, 19 supporting documents for consistency evaluation have been issued, and 5111 generic reference preparations have been accepted for filing In July 2015, to improve the quality of drug clinical research, we began to organize clinical trial data verification, carried out on-site inspection on 203 registered varieties and 463 clinical trial institutions, filed investigations on 27 varieties suspected of data fraud, 11 clinical trial institutions and contract research organizations (cros), and voluntarily withdrawn and verified 1323 registration applications not approved by the enterprise through self inspection Through verification, we have achieved the goal of severely punishing a few and educating the majority, and purified the ecological environment of drug research and development Improve the transparency of review and approval, fully disclose the acceptance, technical review, product inspection and on-site inspection standards and relevant technical requirements of drug registration, disclose the relevant information of acceptance and approval, and guide the applicant to conduct orderly research and development 11 issues of public announcement of approved drugs have been issued Since October 2016, the comprehensive review report of new drugs has been published and accepted social supervision In November 2015, the Standing Committee of the National People's Congress authorized the State Council to carry out pilot drug listing license holder system in ten provinces and cities, greatly mobilizing the enthusiasm of scientific research institutions and researchers Further clarify the main responsibilities of marketing license holders for drug research and development, manufacturing, distribution, use and adverse reaction reports All sectors of society have responded positively and hope to implement it nationwide as soon as possible.
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