Publicity of application for registration of antitumor drugs to be included in the priority review procedure of CDE

According to the announcement of opinions on solving the backlog of drug registration applications and implementing priority review and approval issued by the General Administration of drugs, our center organized experts on April 20, 2016 to review and demonstrate the drug registration applications for anti-tumor application for priority review in accordance with the priority review procedures of drug review center (Trial) The following registration application varieties are urgently needed in clinical practice or have obvious clinical advantages compared with the existing therapeutic drugs in China, so they are proposed to be included in the priority review procedure: No product name acceptance No dosage form Application unit reason 1 lenalidomine cxhs1400204 (raw material) capsule Xinxiang Shuanglu Pharmaceutical Co., Ltd is in urgent need of clinical practice and the first company to apply for cxhs1400266 production, Nanjing Cavendish Bioengineering Technology Co., Ltd cxhs1400267 Cxhs1400268 2 afatinib jxhs1600008 tablet of Beijing Shuanglu Pharmaceutical Co., Ltd This product is the first second generation of EGFR-TKI of Boehringer Ingelheim (China) Investment Co., Ltd It has obvious clinical advantages compared with the first generation of EGFR-TKIs that has been listed in China at present Jxhs1600010 jxhs1600011 is to publicize the above drug varieties and enterprises to be subject to priority review for 5 days If there is any objection during the publicity period, please fill in the appendix "objection form of drug registration application priority review and approval varieties" as required, and feed back to our center: wuq@cde.org.cn Drug evaluation center of State Food and Drug Administration April 24, 2016