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    Home > Medical News > Medical Research Articles > CDE also released a list of drugs for priority review procedures, all of which are children's drugs

    CDE also released a list of drugs for priority review procedures, all of which are children's drugs

    • Last Update: 2016-06-12
    • Source: Internet
    • Author: User
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    According to the opinions of the General 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 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 and approval varieties" as required, and feed back to our center: wuq@cde.org.cn No time of center undertaking acceptance No drug name enterprise name specification indication Reason for selection 1 March 26, 2015 jxhs150026 megestar capsule Aike Tailong Pharmaceutical Trading (Shanghai) Co., Ltd 100mg is used for the treatment of rare disease of C-type Niemann peak disease 2 in children, jxhl1500253 was used on October 14, 2015 Tormoxitine hydrochloride oral solution is used in the treatment of attention deficit / hyperactivity disorder (ADHD) in children and adolescents aged 6 years and over in Shanghai Representative Office of Eli Lilly Asia company Child medication 3 cxhl1502031 dexmedetomidine hydrochloride nasal spray Jiangsu Hengrui Pharmaceutical Co., Ltd on December 1, 2015; Shanghai Hengrui Pharmaceutical Co., Ltd 1.0g: 200 μ g, 50 μ L for each spray, including 10 μ g of dexmedetomidine, No less than 8 sprays per bottle of children's sedative drugs before clinical operation or diagnosis test Drug evaluation center of State Food and Drug Administration June 12, 2016
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