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    Home > Medical News > Medical World News > A large number of children's drugs have been included in the priority review list!

    A large number of children's drugs have been included in the priority review list!

    • Last Update: 2022-08-30
    • Source: Internet
    • Author: User
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    [Pharmaceutical Network Market Analysis] Although the market size of children's medicines has reached 100 billion yuan, domestic children's medicines have not been able to meet the actual clinical needs of children in terms of varieties, dosage forms, specifications and standards
    .

    In recent years, the issue of children's drug use has attracted much attention, and relevant departments have continued to issue a series of favorable policies to support the research and development of children's drugs
    .

    According to incomplete statistics, since the beginning of this year, more than 10 children's drug-related varieties have been included in the priority review list by CDE
    .

    Just recently, the acetaminophen suppository of Zhejiang Erying Pharmaceutical Co.
    , Ltd.
    was included in the priority review, on the grounds that the new varieties, dosage forms and specifications of children's medicines meet the physiological characteristics of children
    .

    The drug is an antipyretic and analgesic drug developed by Erying Company.
    Muscle pain, neuralgia
    .

    According to the data of Minet.
    com, there are currently more than 20 companies that have the approval for the production of acetaminophen suppositories.
    In terms of consistency evaluation, only Zhejiang Erying Pharmaceutical is currently under review as a 3-type imitation drug, and it is expected to become the first company to pass the evaluation
    .

    The Kaglutamic acid tablet of Grand Medicine has also been included in the priority review recently.
    This product is planned to be included in the priority review by CDE on the grounds of "new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children" and is intended to be used for: 1) Hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency; 2) Hyperammonemia caused by isovaleric acidemia; 3) Hyperammonemia caused by methylmalonic acidemia 4) Hyperammonemia caused by propionic acidemia
    .

    At present, only Grand Pharmaceuticals (China) is under review for the production of this product as a 3-type imitation product, and it is expected to win the first approval in China
    .

       The stiripent alcohol dry suspension of Shijiazhuang Siyao, a wholly-owned subsidiary of Shijiazhuang Siyao, is also a rare disease drug that meets the physiological characteristics of children.
    It is mainly used for the treatment of severe muscle tremor in children with epilepsy
    .

    In April this year, the product was included in the list of priority review varieties on the grounds of "new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children"
    .

       Judging from the reasons for the approval of these varieties entering the "green channel", they are mainly new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children.
    However, there are also some drugs that are included in the breakthrough therapy drug program and urgently needed clinical shortages medicines
    .

       For example, the clinical application of clobazam oral suspension submitted by Yichang Renfu Pharmaceutical under the category 3 generic was in May, with the application of "new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children, and other drugs prescribed by the State Food and Drug Administration.
    It was included in the list of priority review varieties on the grounds of "Priority Review and Approval", and was accepted by CDE on August 16, the first in China
    .

    This product is mainly used for the treatment of children with refractory epilepsy and is a rare disease drug
    .

     According to the data from Minet.
    com, currently only Renfu Pharmaceutical and Jinan Kehui Pharmaceutical are developing generic drugs for clobazam, and Renfu Pharmaceutical is progressing faster
    .

       It can be seen that both new drugs and urgently needed drugs in short supply have been supported by favorable policies.
    Accelerating the approval and review and listing progress will bring hope to children's drug patients, and will also boost the confidence and confidence of children's drug research and development enterprises.
    Enthusiasm, the entire children's drug market may usher in a big explosion in the future
    .

       A few days ago, 17 departments also jointly issued the "Guiding Opinions on Further Improving and Implementing Active Reproductive Support Measures", which clearly included assisted reproductive technology projects in the scope of medical insurance fund payment according to procedures
    .

    The industry believes that under the support of policy and market demand, it is expected that children's medicine will have the opportunity to usher in a golden period of development
    .

       Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
    .

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