echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Notice on Regulating the Applicant's Information Remarks for Children's Drug Application

    Notice on Regulating the Applicant's Information Remarks for Children's Drug Application

    • Last Update: 2021-08-10
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    In order to encourage the innovative research and development of children's medicines, optimize the communication and acceptance review efficiency of children's medicines, and improve the records and statistics of children's medicines, the remarks of children's medicines related to the declared varieties are now standardized.


    When submitting clinical trial applications and marketing applications, the applicant should make a note under the "Other Matters" item in the drug registration application form (multiple notes can be noted): apply for children's specific drugs, apply for new children's applications (indications and usage and dosage) , This product belongs to the list of children's drugs that are encouraged to research and develop (indicate the batch and number)


    When submitting a supplementary application, the applicant shall make a remark under the item of "Supplementary Application Content" in the drug registration application form (multiple notes can be noted): application for new children's application (indications and usage and dosage), application for revision of children's application (adaptation) Symptoms, usage and dosage), apply for the addition of special specifications for children, apply for revision of children’s application information in the manual, and apply for other matters related to children’s application


    It will come into force on the date of the announcement


    Hereby inform


    Drug Evaluation Center of the State Drug Administration

    July 9 2021

    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.