echemi logo
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > "Regulations on the Administration of Drug Annual Reports" will come into effect on April 12

    "Regulations on the Administration of Drug Annual Reports" will come into effect on April 12

    • Last Update: 2022-05-12
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit

    In order to standardize the management of the annual reports of drug marketing authorization holders, the State Drug Administration issued a notice today to officially release the "Regulations on the Administration of Drug Annual Reports" (hereinafter referred to as the "Administrative Regulations")

    The purpose of implementing the drug annual report system is to supervise the implementation of the main responsibility for the whole-process quality management of drug marketing authorization holders

    Division of labor and cooperation between drug regulatory departments

    The "Administrative Regulations" make it clear that the State Drug Administration is responsible for guiding the management of the national drug annual report

    The listing authorisation holder is responsible for the annual report

    The "Administrative Regulations" emphasize that the holder of the drug marketing authorization is the main body responsible for the annual report, and is responsible for its authenticity and accuracy

    Online filing + information sharing

    The drug annual report collection module is divided into the enterprise side and the regulatory side

    If the holder fails to submit the annual report as required, in accordance with the provisions of Article 127 of the Drug Administration Law, it shall be ordered to make corrections within a time limit and given a warning; if it fails to make corrections within the time limit, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed.

    This article is an English version of an article which is originally in the Chinese language on 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 A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Related Articles

    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 It will be replied within 5 days.

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