Publicity of drug registration application to be included in the priority review procedure

According to the opinions of the State Administration on solving the backlog of drug registration applications and implementing the priority review and approval (sfjyhg [2016] No 19), our center organized experts to review and demonstrate the drug registration applications that are included in the priority review Now, the drug varieties and applicants to be priority reviewed are publicized 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 varieties", and feed back to our center: wuq@cde.org.cn No acceptance No drug name manufacturer application reason 1 Cxzl1600012 Huoling Shengji granule is a rare disease in clinical trials of new drugs of Shanghai University of traditional Chinese medicine, which is urgently needed Jxhl1600033 darulinestat tablet Xi'an YANGSEN Pharmaceutical Co., Ltd new drug clinical trial anti AIDS drug 3 Cxsl1600011 treatment of hepatitis B adenovirus injection 4 jxhl1600100 / 101 new drug clinical trial of oxitinib tablets AstraZeneca investment (China) Co., Ltd Compared with the existing treatment methods, it has obvious treatment advantages 5 jxhl16000070 salmeterol and ticasone powder inhalation agent Shanghai Novartis Trading Co., Ltd Clinical trials of new drugs for children; clinical urgent need 6 jxhl13000112 mifepride sodium liposome Takeda Pharmaceutical (China) Co., Ltd Clinical trials of new drugs for children; clinical urgent need 7 cxhs1400054 levetiracetam Children's drug of vante Pharmaceutical (Hainan) Co., Ltd is on the market; cxhs1400067 levetiracetam injection is urgently needed in clinic Chengdu Tiantaishan Pharmaceutical Co., Ltd; Sichuan dingnuotaichen Technology Co., Ltd new drugs for children; clinical urgent need 8 cxhs1600005 ibowetai Frontier biopharmaceutical (Nanjing) Co., Ltd new drugs are listed to fight AIDS, innovative drug cxhs1600006 ibovetai for injection Frontier biopharmaceutical (Nanjing) Co., Ltd new drug listed anti AIDS, innovative drug 9 jxhs16000016 / 17 Shugeng glucose sodium injection MSD R & D (China) Co., Ltd has obvious treatment advantages compared with existing treatment methods 10 jxss140006 The new indications of adamumumab injection in EBV Pharmaceutical Trading (Shanghai) Co., Ltd have obvious treatment advantages compared with the existing treatment methods 11 Jxhs1600040 toluenesulfonic acid sorafenib Bayer medical and health care Co., Ltd has obvious advantages in treatment of new indications compared with existing treatment methods 12 cyhs1600036 / 37 ibuprofen injection Chengdu Yuandong biopharmaceutical Co., Ltd generic drugs listed 13 cyhs1501116 / 7 / 8 irinotecan hydrochloride injection Sichuan Huiyu Pharmaceutical Co., Ltd., the first product to be re declared after improvement according to the standard consistent with the quality and efficacy of the original research drug Generic drugs have been approved by European Union for listing 14 cyhs1600041 pemetrexed disodium for injection Sichuan Huiyu Pharmaceutical Co., Ltd has applied for registration of generic drugs in the European Union and obtained MHRA GMP certification cyhs1600043 for pemetrexed disodium for injection Sichuan Huiyu Pharmaceutical Co., Ltd has applied for registration of generic drugs in the European Union and obtained MHRA GMP certification in the UK 15 cyhs1200388 The generic drugs of azithromycin for injection Hainan pril Pharmaceutical Co., Ltd have been put on the market and submitted to anda application in the United States simultaneously, which has passed the FDA on-site inspection Cyhs1201787 Ganciclovir Sodium for injection Hainan Puli Pharmaceutical Co., Ltd generic drugs have been approved to be listed in the European Union and have passed the FDA site certification 17 cyhs1402021 pantoprazole sodium for injection, Hainan Puli Pharmaceutical Co., Ltd submitted the application for EU registration at the same time of listing generic drugs, which has passed the EU GMP inspection Annex 1: drug registration application priority review variety objection form.doc