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On January 7, CDE's official website released 5 guidelines, involving the study of samples for toxicology research of new traditional Chinese medicines, the clinical pharmacokinetics research of modified-release preparations of new drugs, and the research on human bioavailability and bioequivalence of innovative drugs
.
The details are as follows: Under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (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
.
Attachments: 1.
Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (Trial) Under the deployment of the Supervision Administration, the Center for Drug Evaluation organized the revision of the "Technical Guidelines for Drug Non-Clinical Dependence Research"
.
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
.
The "Technical Guiding Principles for Drug Non-Clinical Dependence Research" issued by the former State Food and Drug Administration in 2007 is abolished
.
Attachment: Technical Guiding Principles for Drug Non-Clinical Dependence Research In order to further encourage and guide the rational and standardized pharmacokinetic research of modified-release preparations in improved new drugs and provide technical specifications for reference, the Center for Drug Evaluation organized the formulation of the "Improved New Drugs".
Technical Guiding Principles for Clinical Pharmacokinetic Research of Modified Release Preparations (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 Guiding Principles for Clinical Pharmacokinetics Research of Modified Release Drugs of Modified New Drugs Under the deployment of the Supervision and Administration Bureau, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for Human Bioavailability and Bioequivalence Research of Innovative 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), it is hereby issued with the approval of the State Food and Drug Administration
.
Attachment: Technical Guiding Principles for Human Bioavailability and Bioequivalence Research of Innovative Drugs In order to clarify the relevant technical requirements for random allocation design and implementation in clinical trial research, the Center for Drug Evaluation organized the formulation of the "Guiding Principles for Random Allocation of Drug Clinical Trials (Trial)" (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 random allocation of drug clinical trials (trial)
.
The details are as follows: Under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (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
.
Attachments: 1.
Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (Trial) Under the deployment of the Supervision Administration, the Center for Drug Evaluation organized the revision of the "Technical Guidelines for Drug Non-Clinical Dependence Research"
.
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
.
The "Technical Guiding Principles for Drug Non-Clinical Dependence Research" issued by the former State Food and Drug Administration in 2007 is abolished
.
Attachment: Technical Guiding Principles for Drug Non-Clinical Dependence Research In order to further encourage and guide the rational and standardized pharmacokinetic research of modified-release preparations in improved new drugs and provide technical specifications for reference, the Center for Drug Evaluation organized the formulation of the "Improved New Drugs".
Technical Guiding Principles for Clinical Pharmacokinetic Research of Modified Release Preparations (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 Guiding Principles for Clinical Pharmacokinetics Research of Modified Release Drugs of Modified New Drugs Under the deployment of the Supervision and Administration Bureau, the Center for Drug Evaluation organized the formulation of the "Technical Guidelines for Human Bioavailability and Bioequivalence Research of Innovative 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), it is hereby issued with the approval of the State Food and Drug Administration
.
Attachment: Technical Guiding Principles for Human Bioavailability and Bioequivalence Research of Innovative Drugs In order to clarify the relevant technical requirements for random allocation design and implementation in clinical trial research, the Center for Drug Evaluation organized the formulation of the "Guiding Principles for Random Allocation of Drug Clinical Trials (Trial)" (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 random allocation of drug clinical trials (trial)
