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    Home > Active Ingredient News > Drugs Articles > CDE issues 11 guidelines covering clinical trials, chemical generics, etc.

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

    • Last Update: 2022-01-26
    • Source: Internet
    • Author: User
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    From January 4th to 6th, CDE's official website successively released 11 guiding principles, involving drug clinical trials, chemical generic drugs, and new drug research and development
    .

    details as follows:

    1.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the Guidelines for the Design of Clinical Trials of Drugs for the Prevention of Nausea and Vomiting Caused by Antineoplastic Drugs (Trial) (No.
    70, 2021)

    1.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the Guidelines for the Design of Clinical Trials of Drugs for the Prevention of Nausea and Vomiting Caused by Antineoplastic Drugs (Trial) (No.
    70, 2021)

    In order to encourage the research and development of new drugs, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated the Guidelines for the Design of Clinical Trials of Drugs for the Prevention of Nausea and Vomiting Caused by Antineoplastic 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: Guidelines for the Design of Clinical Trials of Drugs for the Prevention of Nausea and Vomiting Caused by Antineoplastic Drugs (Trial)

    Guidelines for Design of Clinical Trials of Drugs for Preventing Nausea and Vomiting Caused by Antineoplastic Drugs (Trial)

    2.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on the issuance of the "Technical Guidelines for Pharmacokinetic Research in Patients with Renal Insufficiency (Trial)" (No.
    69 of 2021)

    2.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on the issuance of the "Technical Guidelines for Pharmacokinetic Research in Patients with Renal Insufficiency (Trial)" (No.
    69 of 2021)

    Pharmacokinetic studies in patients with renal insufficiency are usually one of the contents of clinical pharmacology studies of innovative drugs, and the results of the studies are the scientific basis to support the decision-making of the corresponding population to adjust usage and dosage
    .
    In order to remind the sponsor of the overall consideration and data analysis of related research, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for Pharmacokinetic Research in Patients with Renal Insufficiency (Trial)"

    .

    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

    .
    In the event of inconsistencies between previously published guidelines and this guideline, this guideline shall prevail

    .

    Attachment: Technical Guidelines for Pharmacokinetic Research in Patients with Renal Insufficiency (Trial)

    Technical guidelines for pharmacokinetic studies in patients with renal insufficiency (trial) Technical guidelines for pharmacokinetic studies in patients with renal insufficiency (trial)

    3.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Guidelines for Writing "Clinical Risk Management Plans (Trial)" (2021 No.
    68)

    3.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Guidelines for Writing "Clinical Risk Management Plans (Trial)" (2021 No.
    68)

    In order to encourage the research and development of new drugs, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated the "Guidelines for Writing a "Clinical Risk Management Plan" (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: Guidelines for Writing "Clinical Risk Management Plan" (for Trial Implementation)

    Guidelines for Writing "Clinical Risk Management Plan" (Trial) Guidelines for Writing "Clinical Risk Management Plan" (Trial)

    4.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for Clinical Trials of Direct Antiviral Drugs for Chronic Hepatitis C" (No.
    67 of 2021)

    4.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for Clinical Trials of Direct Antiviral Drugs for Chronic Hepatitis C" (No.
    67 of 2021)

    In order to guide the scientific research and development and evaluation of direct antiviral drugs for chronic hepatitis C and provide technical standards for reference, the Center for Drug Evaluation has formulated the "Technical Guidelines for Clinical Trials of Direct Antiviral Drugs for Chronic Hepatitis C" (see the 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 direct-acting antiviral drugs in chronic viral hepatitis C

    Technical guidelines for clinical trials of direct-acting antiviral drugs in chronic viral hepatitis C Technical guidelines for clinical trials of direct-acting antiviral drugs in chronic viral hepatitis

    5.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for Clinical Trials of Ulcerative Colitis Drugs" (No.
    66 of 2021)

    5.
    Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the "Technical Guidelines for Clinical Trials of Ulcerative Colitis Drugs" (No.
    66 of 2021)

    In order to further standardize and guide the clinical trials of drugs for the treatment of ulcerative colitis, and to provide technical specifications that can be referred to, under the deployment of the State Drug Administration, the Center for Drug Evaluation organized and formulated 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

    Technical Guidelines for Clinical Trials of Ulcerative Colitis Drugs 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)

    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

    Technical Guidelines for Clinical Trials of Crohn's Disease Drugs Technical Guidelines for Clinical Trials of Crohn's Disease Drugs

    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)

    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 "Technical Guidelines for 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 the Issuance of the Procedures for Issuing the Technical Guidance Principles for Drugs" (Medical Administration Comprehensive Drug Administration [2020] No.
    9), it is hereby issued upon the review and approval of the State Food and Drug Administration.
    to execute

    .

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

    Technical Guiding Principles for Food Impact Research During 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)

    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

    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)

    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)

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

    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)

    Technical Guiding Principles for Crystal Form Research of Chemical Generic Drugs (Trial) Technical Guiding Principles for Chemical Generic Drug Crystal Form Research (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)

    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

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