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    Home > Medical News > Latest Medical News > CDE issues 11 guidelines covering clinical trials, chemical generics, etc.

    CDE issues 11 guidelines covering clinical trials, chemical generics, etc.

    • Last Update: 2022-01-21
    • Source: Internet
    • Author: User
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    In order to further standardize and guide the clinical trials of drugs for the treatment of ulcerative colitis, and provide technical specifications for reference, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for Clinical Trials of Drugs for the Treatment of Ulcerative Colitis" (see attachment)
    .
    In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
    9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
    .


    Annex: Technical Guidelines for Clinical Trials of Ulcerative Colitis Drugs


    6.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for Clinical Trials of Drugs for the Treatment of Crohn's Disease" (2021 No.
    65)


    In order to further standardize and guide the clinical trials of Crohn's disease treatment drugs and provide reference technical specifications, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of "Technical Guidelines for Clinical Trials of Crohn's Disease Treatment Drugs" (see attachment)
    .
    In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
    9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
    .


    Attachment: Technical Guidelines for Clinical Trials of Drugs for the Treatment of Crohn's Disease


    7.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for Food Impact Research in the Process of New Drug Development" (2021 No.
    64)


    In order to promote the early clinical research and development of new drugs, guide drug research and development enterprises to carry out food impact research in a reasonable and standardized manner, and further guide the implementation and evaluation of food impact research in the process of new drug research and development, the Center for Drug Evaluation organized the drafting of the "Technical Guiding Principles of Food Impact Research in the Process of New Drug Research and Development".
    "
    .


    In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
    9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to execute
    .


    Annex: Technical Guiding Principles for Food Impact Research in New Drug Development



    8.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Guiding Principles for Drug Clinical Trial Data Management and Statistical Analysis Plans" (2021 No.
    63)


    In order to adapt to the continuous development of clinical trial data management and statistical analysis technologies and methods in recent years, and to cooperate with the implementation and implementation of the relevant ICH guidelines, the Center for Drug Evaluation organized the revision of the "Medical Clinical Trial Data Management and Statistical Analysis Guidelines" issued in July 2016.
    Planning and Reporting Guidelines, and formed the Guidelines for Drug Clinical Trial Data Management and Statistical Analysis Planning (see attachment)
    .
    In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
    9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
    .


    Annex: Guidelines for Data Management and Statistical Analysis Plans for Drug Clinical Trials

     
    9.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Guiding Principles for the Application of Patient-Reported Outcomes in Drug Clinical Development (Trial)" (No.
    62 of 2021)


    In order to encourage the concept of patient-centered new drug development and scientific and rational use of patient-reported outcomes, the Center for Drug Evaluation organized and formulated the Guidelines for the Application of Patient-Reported Outcomes in Drug Clinical Research and Development (for Trial Implementation) (see attachment)
    .
    In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
    9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
    .


    Annex: Guidelines for the Application of Patient-Reported Outcomes in Drug Clinical Development (Trial)



    10.
    Announcement of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guiding Principles for Crystal Form Research of Chemical Generic Drugs (Trial)" (2021 No.
    61)


    In order to standardize and guide the crystal form research of chemical generic drugs, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated the "Technical Guidance Principles for the Crystal Form Research of Chemical Generic Drugs (for Trial Implementation)" (see attachment)
    .
    In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
    9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
    .


    Attachment: Technical Guidelines for Crystal Form Research of Chemical Generic Drugs (Trial)



    11.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for Writing Safety Reference Information in the Investigator's Manual" (2021 No.
    60)


    In order to cooperate with the implementation of the "Measures for the Administration of Drug Registration" and "Measures for the Quality Management of Pharmacovigilance", and to standardize the reporting of suspicious and unexpected serious adverse reactions by sponsors during clinical trials, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated The "Technical Guidelines for Writing Safety Reference Information in the Investigator's Handbook" (see appendix)
    .
    In accordance with the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Yijian Zongyaoguan [2020] No.
    9), and with the approval of the State Food and Drug Administration, it is hereby issued from the date of issuance to be implemented
    .


    Attachment: Technical Guidelines for Writing Safety Reference Information in the Investigator's Handbook

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