The State Food and Drug Administration and the Center for Drug Evaluation issued 4 guiding principles related to traditional Chinese medicine

On January 7, the State Food and Drug Administration issued the "Technical Guidelines for Revision of Safety Information Items in the Instruction Sheet of Listed Chinese Medicines (Trial)", and CDE issued "Guidelines for Compiling Traditional Chinese Medicine Theory Application Materials for New Chinese Medicine Compound Preparations (Trial)" and other 3 items guiding principles
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The details are as follows: Notice of the State Food and Drug Administration on Issuing the "Technical Guiding Principles for Revision of the Contents of the Safety Information Items in the Package Inserts of Listed Chinese Medicines (Trial)" (No.
1, 2022) In order to further guide the drug marketing authorization holders on the safety of the package inserts of marketed Chinese medicines To revise the content of information items, strengthen the management of the whole life cycle of traditional Chinese medicine, and ensure the safety of public medication, the State Food and Drug Administration organized the formulation of the "Technical Guiding Principles for Revising the Contents of Safety Information Items in the Instruction Sheet of Listed Chinese Medicines (Trial)", which is hereby issued
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Attachments: 1.
"Technical Guiding Principles for Revision of Safety Information Items in Package Inserts of Listed Chinese Medicines (Trial)" 2.
Drafting of "Technical Guidelines for Revision of Safety Information Items in Package Inserts of Listed Chinese Medicines (Trial)" Announcement (No.
42, 2021) of the "Guidelines for Writing Traditional Chinese Medicine Theory Application Materials (Trial)" and "Guidelines for Writing Instructions for Traditional Chinese Medicine Compound Preparations (Trial)" (No.
42, 2021) To accelerate the construction of traditional Chinese medicine theory, A Chinese medicine registration review evidence system that combines human experience and clinical trials to standardize the writing of theoretical application materials of traditional Chinese medicine and the contents of the instructions for traditional Chinese medicine compound preparations.
Under the deployment of the State Drug Administration, the Drug Evaluation Center organized Formulated the "Guidelines for Compiling Traditional Chinese Medicine Theory Application Materials for New Chinese Medicine Compound Preparations (for Trial Implementation)" (see Annex 1) and "Guidelines for Writing Instructions for Chinese Medicine Compound Preparations with Ancient Classic Famous Prescriptions (for Trial Implementation)" (see Annex 2)
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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
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Attachments: 1.
Guiding principles for writing Chinese medicine theory application materials for new traditional Chinese medicine compound preparations (trial) 2.
Guiding principles for writing instructions for traditional Chinese medicine compound preparations with ancient classic and famous prescriptions (trial) Circular (No.
1, 2022) "Technical Guidelines for Research with Samples (Trial)" Under the deployment of the State Drug Administration, the Center for Drug Evaluation organized the formulation of "Technical Guidelines for Research on Samples for Toxicology Research of New Chinese Medicines (Trial)" " (see appendix)
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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
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Attachments: 1.
Technical Guidelines for the Study of Samples for Toxicology Research of New Chinese Medicines (Trial) 2.
Drafting Instructions for "Technical Guidelines for the Study of Samples for Toxicology of New Chinese Medicines (Trial)"