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    Home > Medical News > Medical World News > Seven questions about the draft of the Regulations on the Administration of the Annual Report on Drugs

    Seven questions about the draft of the Regulations on the Administration of the Annual Report on Drugs

    • Last Update: 2021-01-11
    • Source: Internet
    • Author: User
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    Article 2 "Article 2 Basic Requirements" Annual Report refers to the report formed by the holder collecting information on the production and sale, post-marketing research, risk management and other aspects of the drugs held by the holder in accordance with the natural annual period.
    annual report cannot replace the drug registration management, production administrative license or the matters required by the drug regulatory department for filing by the holder as required by the drug laws and regulations.
    " refers only to "the annual report is not a substitute for the drug registration management, the production administrative license or the drug regulatory authority required by the drug regulatory authority to be filed by the holder", and does not mention that "the annual report is not a substitute for the drug regulatory authority requiring approval."
    2 Drug Annual Report Management Code (draft for comments) does not mention whether the annual report is an annual report by one enterprise or by one species? Will it be clear? 3 When will the annual report information system referred to in Article 8 of the Regulations on the Management of The Annual Report of Pharmaceuticals (Draft for Comments) be put into use? 4 Pharmaceutical annual report template the first major item "drug market licensing licensee commitment" in ... The relevant procedures have been completed in accordance with the requirements for the filing or reporting of matters required by the drug regulatory authorities.
    in "The Report" was amended to "... The relevant procedures have been completed in accordance with the requirements for the approval or filing of matters requested by the drug regulatory department.
    ": Article 79 of the Drug Administration Act (Presidential Decree No. 31 of 2019) provides classification management for changes in the production of pharmaceuticals according to the extent to which they have a risk and impact on the safety, effectiveness and quality control of the drug.
    a major change, it shall be approved by the drug regulatory department under the State Council, and other changes shall be filed or reported in accordance with the provisions of the drug supervision and administration department under the State Council.
    Registered Management Measures (General Administration Order No. 28 of 2020) Article 77 Changes after the listing of a drug shall be classified according to the degree of risk and impact it has on the safety, effectiveness and quality control of the drug, and shall be divided into approval category changes, filing category changes and reporting category changes.
    Article 78 The following changes shall be declared by the holder by means of a supplementary application and implemented upon approval: (1) major changes in the course of the production of the drug; (2) changes to the contents of the drug description relating to the validity and other contents that increase the safety risk; (3) the holder transfers the drug listing license; and (4) other changes requiring approval as prescribed by the State Drug Administration.
    Article 79 For the following changes, the holder shall, before the changes are implemented, report them to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government for the record: (1) a medium change in the pharmaceutical production process; (2) a change in the contents of the drug packaging label; (3) a sub-packaging of the drug; and (4) other changes requiring the record as prescribed by the State Drug Administration.
    the above-mentioned changes in the production of drugs abroad, they shall be reported to the Drug Review Center for the record before the implementation of the changes.
    procedures and requirements for the filing of drug sub-packaging shall be formulated and issued by the Drug Review Center.
    80 of the following changes, the holder shall report in the annual report: (1) minor changes in the course of drug production;
    the above-mentioned regulations stipulate that changes in the approval category and the filing category need to be approved or filed before they are implemented, and minor changes or other changes required to be reported by the State Drug Administration are reported in the annual report. The second item of the
    5 Drug Annual Report Template, "Drug Listing License Holder Report Information", includes only four drug listing license holder names, drug production license numbers, unified social credit codes, production address information content is less, it is recommended to increase the listing license holder registration address, business head, production person in charge, quality person in charge, quality licensee and other information.
    6 "Variety Reporting Information" in the third item of the annual drug report template: 1. Product Basics Table 1: (for Chinese medicines, chemicals, biological products, vaccine manufacturers or listed holders to fill in) lack of implementation standards/registration standards, recommended increases.
    the guiding principles and management measures for changes to listed medicines used in the 7th Annual Report template issued? Expect.
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