Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability

Yu SUN; De-wen LIU; Hai-ruo WEN

doi:10.13422/j.cnki.syfjx.20210747

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Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability

Pharmacy Administration | 更新时间：2021-07-28

- Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 27, Issue 17, Pages: 178-185(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.中国中医科学院中药研究所，北京 100700
  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.20210747
  CLC： TS2;R282;R22
- Received：28 November 2020，
  
  Published Online：18 January 2021，
  
  Published：05 September 2021
- 稿件说明：
移动端阅览
孙昱,刘德文,文海若.从FDA食品追溯到中药材追溯的思考[J].中国实验方剂学杂志,2021,27(17):178-185.

SUN Yu,LIU De-wen,WEN Hai-ruo.Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(17):178-185.
孙昱,刘德文,文海若.从FDA食品追溯到中药材追溯的思考[J].中国实验方剂学杂志,2021,27(17):178-185. DOI： 10.13422/j.cnki.syfjx.20210747.

SUN Yu,LIU De-wen,WEN Hai-ruo.Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(17):178-185. DOI： 10.13422/j.cnki.syfjx.20210747.

摘要

“药材好，药才好”，中药材追溯与中药产业的高质量发展密切相关。笔者拟分析美国食品药品监督管理局（FDA）食品追溯相关的“新时代智能食品安全蓝图”和《食品可追溯性建议规则》，包括食品可追溯性清单、关键跟踪事件及豁免情形示例。通过研究FDA食品追溯体系建设的过程和考虑，以及FDA食品追溯体系中与中药材有一定相关性的新鲜草药和蔬果的具体追溯要求，一方面可为中药材追溯提供研究素材，另一方面也可为我国的食品追溯体系建设提供参考。梳理出适合目前中药发展现状的中药材追溯体系建设思路主要有4个方面：①基于中药材的风险控制，确定中药材追溯清单；②确定中药材产业链中的关键追溯环节和关键追溯信息，标准化中药材的可追溯信息；③在中药材追溯中体现中药材品质信息；④在中药材追溯清单的范围内，选择溯源工作基础较好的中药材鼓励企业自愿进行追溯。

Abstract

As a Chinese saying goes， "good Chinese medicinal material makes good medicine"， the traceability of Chinese medicinal materials is closely related to the high-quality development of Chinese medicine industry. This article intends to analyze the "new era of smarter food safety blueprint" and

Proposed Rule for Food Traceability

related to food traceability of the U.S. Food and Drug Administration （FDA）， including food traceability list， critical tracking events， and examples of exemptions. By studying the process and consideration of the construction of the FDA food traceability system， as well as the specific traceability requirements of fresh herbs， vegetables and fruits in the FDA food traceability system that are related to Chinese medicinal materials， on the one hand， it provides research materials for the communication and discussion of Chinese medicinal materials traceability， on the other hand， it also provides reference for the construction of food traceability system in China. To sort out the idea of constructing a traceability system for Chinese medicinal materials suitable for the current development status of traditional Chinese medicine， the contents to be considered are as follows：①To determine the traceability list of Chinese medicinal materials based on the risk control of Chinese medicinal materials. ②Determine the critical tracking links and information in the Chinese medicinal materials industry chain， and standardize the traceability information of Chinese medicinal materials. ③The quality information of Chinese medicinal materials should be reflected in the traceability of Chinese medicinal materials. ④Within the scope of the traceability list of Chinese medicinal materials， enterprises should be encouraged to make voluntary traceability by selecting Chinese medicinal materials with a good foundation of traceability work.

关键词

Keywords

references

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