Preliminary Considerations on Management Mode and Technical Evaluation of Traditional Chinese Medicine with Same Name and Prescription

Yu SUN; Gan XU; Qi WANG; Shuang-cheng MA

doi:10.13422/j.cnki.syfjx.20210347

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Preliminary Considerations on Management Mode and Technical Evaluation of Traditional Chinese Medicine with Same Name and Prescription

Pharmacy Administration | 更新时间：2021-06-25

- Preliminary Considerations on Management Mode and Technical Evaluation of Traditional Chinese Medicine with Same Name and Prescription
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 27, Issue 13, Pages: 179-183(2021)
- 作者机构：
  
  1.国家药品监督管理局药品审评中心，北京 100022
  2.北京中医药大学，北京 102248
  3.中国食品药品检定研究院，北京 100050
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20210347
  CLC： R97;R286;R94
- Received：12 October 2020，
  
  Published Online：29 December 2020，
  
  Published：05 July 2021
- 稿件说明：
移动端阅览
孙昱,徐敢,汪祺等.中药同名同方药的管理模式和技术评价初步思考[J].中国实验方剂学杂志,2021,27(13):179-183.

SUN Yu,XU Gan,WANG Qi,et al.Preliminary Considerations on Management Mode and Technical Evaluation of Traditional Chinese Medicine with Same Name and Prescription[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(13):179-183.
孙昱,徐敢,汪祺等.中药同名同方药的管理模式和技术评价初步思考[J].中国实验方剂学杂志,2021,27(13):179-183. DOI： 10.13422/j.cnki.syfjx.20210347.

SUN Yu,XU Gan,WANG Qi,et al.Preliminary Considerations on Management Mode and Technical Evaluation of Traditional Chinese Medicine with Same Name and Prescription[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(13):179-183. DOI： 10.13422/j.cnki.syfjx.20210347.

摘要

随着《中药注册分类及申报资料要求》的发布，中药同名同方药的相关管理和技术文件有待进一步研究制定。笔者拟对中药同名同方药的管理模式和技术评价进行探讨，以期为中药同名同方药的管理和技术文件制定提供参考。探讨的问题包括采用何种管理模式，如何选定对照同名同方药，是否需要对适应症风险等级进行划分，是否需要限定于中、低风险适应症，如何进行相似性/一致性技术评价。笔者从技术文件研究制定的角度，主要聚焦于技术层面进行探讨。然而，由于中药同名同方药的管理模式和技术评价在理论上还存在其他的可能性，因此，该文作为中药同名同方药管理和技术评价的初步研究小结，有待更多的学者和业界专家关注并参与研究此项工作。

Abstract

With the publication of

Registration and Classification of Traditional Chinese Medicine （TCM） and Application Data Requirements

， the related management and technical documents of TCM with the same name and prescription need to be further studied and formulated. In this paper， the management mode and technical evaluation of TCM with the same name and prescription are discussed to provide reference for the formulation of management and technical documents of TCM with the same name and prescription. The issues to be discussed include which management mode to adopt， how to select the control drugs with the same name and prescription， whether the indication risk level should be divided， whether the indication should be limited to medium and low risk， and how to carry out the technical evaluation of similarity/consistency. From the perspective of technical document research and formulation， this paper mainly focuses on the technical level. However， there are still other theoretical possibilities in the management mode and technical evaluation of TCM with the same name and prescription. Therefore， this paper， as a preliminary summary of the management and technical evaluation of TCM with the same name and prescription， needs more scholars and industry experts to pay attention to and participate in this work.

关键词

Keywords

references

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