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

Source: CDE 2016-06-12 according to the opinions of the State Administration on solving the backlog of drug registration applications and implementing the priority review and approval ([2016] No 19), our center organized experts to review and demonstrate the drug registration applications applying for the priority review procedure, and now publicized the drug varieties and applicants to be priority reviewed 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 S / N center undertaking time acceptance No drug name enterprise name specification indication selected reason 1 March 26, 2015 jxhs150026 megestat capsule aiketelong pharmaceutical trade (Shanghai) Co., Ltd 100mg is used for the treatment of rare C-type Niemann peak disease, children medication 2 On October 14, 2015, jxhl1500253 tormoxitine hydrochloride oral solution was used to treat attention deficit / hyperactivity disorder (ADHD) in children and adolescents aged 6 and over in Shanghai Representative Office of Eli Lilly Asia company Children medication 3 on December 1, 2015, cxhl1502031 dexmedetomidine hydrochloride nasal spray Jiangsu Hengrui Pharmaceutical Co., Ltd.; Shanghai Hengrui Pharmaceutical Co., Ltd 1.0g: 200 μ g, 50 μ L for each spray, including 10 μ g dexmedetomidine, No less than 8 sprays per bottle for sedation of children before clinical operation or diagnosis test drug evaluation center of State Food and Drug Administration June 12, 2016