从FDA食品追溯到中药材追溯的思考

孙昱; 刘德文; 文海若

doi:10.13422/j.cnki.syfjx.20210747

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从FDA食品追溯到中药材追溯的思考

药事管理 | 更新时间：2021-07-28

- 从FDA食品追溯到中药材追溯的思考
- Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability
- 中国实验方剂学杂志 2021年27卷第17期页码：178-185
- 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：
  
  孙昱，博士，从事药品政策及技术评价研究，E-mail：sunyu_amber@126.com
  刘德文，博士，助理研究员，从事中药制剂学及中药炮制学研究，Tel：010-84076882，E-mail：dwliu@icmm.ac.cn
  文海若，博士，研究员，从事药理毒理研究，Tel：010-67876252，E-mail：hairuowen@163.com
- 基金信息：
  
  中央级公益性科研院所基本科研业务费项目(ZXKT19026);国家自然科学基金项目(81503347)
- DOI：10.13422/j.cnki.syfjx.20210747
  中图分类号： TS2;R282;R22
- 收稿日期：2020-11-28，
  
  网络出版日期：2021-01-18，
  
  纸质出版日期：2021-09-05
- 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

中国共产党中央委员会，国务院 . 中共中央国务院关于促进中医药传承创新发展的意见［EB/OL］.（ 2019-10-26 ）［ 2020-11-28 ］. http：//www.gov.cn/zhengce/2019-10/26/content_5445336.htm http://www.gov.cn/zhengce/2019-10/26/content_5445336.htm .

国家药品监督管理局 . 国家药监局关于促进中药传承创新发展的实施意见［EB/OL］.（ 2020-12-25 ）［ 2020-12-28 ］. https：//www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20201225163906151.html https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20201225163906151.html .

Food and Drug Administration （FDA） . New era of smarter food safety blueprint ［EB/OL］.（ 2020-07-13 ）［ 2020-11-28 ］. https：//www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-blueprint https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-blueprint .

FDA . FSMA proposed rule for food traceability ［EB/OL］.（ 2020-11-05 ）［ 2020-11-28 ］. https：//www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-food-traceability https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-food-traceability .

FDA . Requirements for additional traceability records for certain foods ［EB/OL］.（ 2020-09-23 ）［ 2020-11-28 ］. https：//www.federalregister.gov/documents/2020/09/23/2020-20100/requirements-for-additional-traceability-records-for-certain-foods https://www.federalregister.gov/documents/2020/09/23/2020-20100/requirements-for-additional-traceability-records-for-certain-foods .

FDA . Food traceability list ［EB/OL］.（ 2020-11-05 ）［ 2020-11-28 ］. https：//www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list .

FDA . Full text of the food safety modernization act （FSMA）［EB/OL］.（ 2017-12-13 ）［ 2020-11-28 ］. https：//www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma#SEC204 https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma#SEC204 .

FDA . Which key data elements would apply to me？［EB/OL］.（ 2020-09-21 ）［ 2020-11-28 ］. https：//www.fda.gov/food/food-safety-modernization-act-fsma/which-key-data-elements-would-apply-me https://www.fda.gov/food/food-safety-modernization-act-fsma/which-key-data-elements-would-apply-me .

FDA . Methodological approach to developing a risk-ranking model for food tracing FSMA section 204 （ 21 U.S. Code § 2223 ）［EB/OL］.（ 2020-08-21 ）［ 2020-11-28 ］. https：//www.fda.gov/media/142247/download https://www.fda.gov/media/142247/download .

FDA . Risk-ranking model for food tracing：results for commodity-hazard pairs ［EB/OL］.（ 2020-08-21 ）［ 2020-11-28 ］. https：//www.fda.gov/media/143470/download https://www.fda.gov/media/143470/download .

FDA . Risk-ranking model for food tracing：results for commodities ［EB/OL］.（ 2020-08-21 ）［ 2020-11-28 ］. https：//www.fda.gov/media/143469/download https://www.fda.gov/media/143469/download .

FDA . Proposed rule：requirements for additional traceability records for certain foods key terms glossary ［EB/OL］.（ 2020-10-05 ）［ 2020-11-28 ］. https：//www.fda.gov/media/143468/download https://www.fda.gov/media/143468/download .

FDA . Which key data elements would apply to me？［EB/OL］.（ 2020-09-21 ）［ 2020-11-28 ］. https：//www.fda.gov/food/food-safety-modernization-act-fsma/which-key-data-elements-would-apply-me#growing https://www.fda.gov/food/food-safety-modernization-act-fsma/which-key-data-elements-would-apply-me#growing .

FDA . First receiver examples ［EB/OL］.（ 2020-09-21 ）［ 2020-11-28 ］. https：//www.fda.gov/media/142284/download https://www.fda.gov/media/142284/download .

FDA . Creation and transformation ［EB/OL］.（ 2020-09-21 ）［ 2020-11-28 ］. https：//www.fda.gov/media/142285/download https://www.fda.gov/media/142285/download .

FDA . Commodity specific food safety guidelines for the production ，harvest，post-harvest，and processing unit operations of fresh culinary herbs［EB/OL］.（ 2013-01-24 ）［ 2020-11-28 ］. https：//www.fda.gov/media/85323/download https://www.fda.gov/media/85323/download .

FDA . Commodity specific food safety guidelines for the fresh tomato supply chain ［EB/OL］.（ 2018-09-24 ）［ 2020-11-28 ］. https：//www.fda.gov/media/129790/download https://www.fda.gov/media/129790/download .

中国共产党中央委员会 . 中共中央关于制定国民经济和社会发展第十四个五年规划和二〇三五年远景目标的建议［EB/OL］.（ 2020-11-03 ）［ 2020-11-28 ］. http：//www.gov.cn/zhengce/2020-11/03/content_5556991.htm http://www.gov.cn/zhengce/2020-11/03/content_5556991.htm .

邓彬，国锦琳，华桦，等 . 基于全产业链标准整合的中药材质量保障与溯源系统［J/OL］. 世界中医药： 1 - 9 ［ 2021-01-17 ］. http：//kns.cnki.net/kcms/detail/11.5529.R.20200429.1549.018.html http://kns.cnki.net/kcms/detail/11.5529.R.20200429.1549.018.html .

谢春辉，熊蔚维，李国妹，等 . 基于区块链技术的中药材质量安全溯源系统设计［J］. 云南民族大学学报：自然科学版， 2020 ， 29 （ 1 ）： 84 - 90 .

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 .

李灿，曲建博，周跃华 . 中药材信息化追溯体系建设的现状与思考［J］. 中国现代中药， 2020 ， 22 （ 9 ）： 1419 - 1422 .

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