CHINAFOODANDDRUGNEWSLETTER-中国食品药品.PDF

2018. Volume 4 CHINA FOOD AND DRUG NEWSLETTER 中国食品药品国际交流中心 施维雅(天津）制药有限公司 National Drug Administration and NHC Issued the 国家药品监督管理局 国家卫生 Announcement on Matters Concerning the Optimization 健康委员会发布《关于优化药品 of Drug Registration Review Approval 注册审评审批有关事宜的公告》 As per the Opinions on Deepening the that are seriously life-threatening and 为贯彻落实《中共中央办公厅 国务院办 Review and Approval System Reform and that have no effective treatment means, 公厅关于深化审评审批制度改革鼓励药品医疗 Encouraging the Drug and Medical Device and rare diseases, if applicants for 器械创新的意见》（厅字〔2017〕42号）、《国 Innovation of the General Office of the registration of these imported drugs 务院关于改革药品医疗器械审评审批制度的意 CPC Central Committee and the General have confirmed after study there is no 见》（国发〔2015〕44号），提高创新药上市审 Office of the State Council (CPC Central any ethnic difference, they can directly 批效率，科学简化审批程序，2018年5月23 日， Committee State Council [2017] No. apply for drug marketing registrations via 国家药品监督管理局 国家卫生健康委员会发 42), and the Opinions on the Reform of submitting the clinical trial data obtained 布《关于优化药品注册审评审批有关事宜的公 the Review Approval System for Drugs overseas. For the applications for clinical 告》（2018年第23号），就有关事宜公告如下： and Medical Devices of the State Council trials of the above-mentioned imported