CDE publicizes the application of HCV drug registration to be included in the priority review procedure

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 China, our center organized experts on April 12, 2016 to discuss the drug registration applications for treatment of indications of hepatitis C virus infection for priority review in accordance with the work procedures for priority review of drug review center (Trial) The following drugs are compared with the existing treatment in China Hepatitis C virus drugs have obvious clinical advantages, and are to be included in the priority review procedure: product name acceptance No dosage form specification application unit Asc16 ravidasvir tablet cxhl1500710 tablet 50mg Geli Biotechnology (Hangzhou) Co., Ltd Fularevir and capsule CXHL1501084 CXHL1501085 capsule 100mg KW-136 and capsule of Taijing pharmaceutical R & D (Beijing) Co., Ltd Cxhl1401836, cxhl1401837, cxhl1401838 tablet, 10mg, 60mg, Beijing Kaine Technology Co., Ltd ximerewei capsule Simeprevir capsules jxhl1500151 capsules 150mg asunaprevir soft capsules of Xi'an Janssen Pharmaceutical Co., Ltd Jxhl16000016 soft capsule 100mg Bristol Myers Squibb (China) Investment Co., Ltd daclatasvirdihydrochloride tablets Jxhl16000015 tablet 60mg Bristol Myers Squibb (China) Investment Co., Ltd asunaprevir soft capsules Jxhl1400384 soft capsule 100mg Bristol Myers Squibb (China) Investment Co., Ltd daclatasvirdihydrochloride tablets Jxhl1400385 tablet 60mg Bristol Myers Squibb (China) Investment Co., Ltd sofosbuvirtables jxhl1500145 Tablets 400mg dasabuvir tablets jxhl1500298 Tablet 250mg abipavir, paritaprevir and Rito navir tablets jxhl150313 Tablet 12.5mg/75mg/50mg EBV Pharmaceutical Trading (Shanghai) Co., Ltd ledipasvir / sofosbuvirtables jxhl150329 The Beijing Representative Office of 90mg / 400mg Hong Kong geelia Science Co., Ltd now publicizes 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 Appendix 1 of April 18, 2016: Drug registration application priority review approval variety objection form.doc