Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging. Further technical evaluation after market introduction should be carried out on safety, health function and other aspects of those widely used commercial scale production products. According to the analysis report on the consumption situation of post-marketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago, the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support. Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence, this paper analyzes the post-marketing evaluation content, evidence source construction, evidence classification and classification of functional food, and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points, so as to provide insights into evidence system research in this field in the future.
Citation：
WANG Jinbo, CHEN Guangyao. Reflections on the construction of the evidence body of technical evaluation of functional foods after market introduction. Chinese Journal of Evidence-Based Medicine, 2020, 20(11): 1247-1250. doi: 10.7507/1672-2531.202005010
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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- 1. 中共中央, 国务院. “健康中国 2030”规划纲要, 2016-10-25. Available at: http://www.gov.cn/gongbao/2016-11/20/content_5133024.htm.
- 2. 国务院办公厅. 关于印发国民营养计划(2017-2030年)的通知(国办发〔2017〕60 号), 2017-6-30. Available at: http://www.gov.cn/zhengce/content/2017-07/13/content_5210134.htm?trs=1.
- 3. 国家食品药品监督管理总局. 《保健食品注册与备案管理办法》(国家食品药品监督管理总局令第 22 号), 2016-2-26. Available at: http://www.gov.cn/gongbao/content/2016/content_5074083.htm.
- 4. 国家市场监督管理总局. 《保健食品原料目录与保健功能目录管理办法》(国家市场监督管理总局令第 13 号), 2019-8-20. Available at: http://www.gov.cn/gongbao/content/2019/content_5449662.htm.
- 5. 国家食品药品监督管理总局. 关于印发保健食品注册审评审批工作细则的通知(食药监食监三〔2016〕139 号), 2016-11-14. Available at: http://news.foodmate.net/2016/11/404050.html.
- 6. 国家食品药品监督管理总局. 关于发布保健食品注册申请服务指南的通告(2016 年第 167 号), 2016-12-19. Available at: http://news.foodmate.net/2016/12/409625.html.
- 7. 卫生部. 关于进一步规范保健食品原料管理的通知(卫法监发〔2002〕51 号), 2002-2-28. Available at: http://www.eshian.com/laws/10461.html.
- 8. Guyatt GH, Haynes RB, Jaeschke RZ, et al. Users' guides to the medical literature: ⅩⅩⅤ. Evidence-based medicine: principles for applying the users' guides to patient care. Evidence-based medicine working group. JAMA, 2000, 284(10): 1290-1296.
- 9. 廖星, 谢雁鸣. 上市后中药临床安全性循证证据体评价研究. 中国中西医结合杂志, 2017, 37(1): 109-114.
- 10. 廖星, 谢雁鸣. 构建中药上市后安全性评价证据体的思考. 世界中医药, 2014, 9(9): 1141-1144.
- 11. 国家食品药品监督管理总局办公厅. 公开征求关于进一步加强保健食品监管工作的意见(征求意见稿), 2017-4-28. Available at: http://www.gov.cn/hudong/2017-05/03/content_5190497.htm.
- 12. 国家卫生和计划生育委员会, 财政部, 国家中医药管理局. 关于做好 2017 年国家基本公共卫生服务项目工作的通知(国卫基层发〔2017〕46 号), 2017-9-6. Available at: http://www.satcm.gov.cn/yizhengsi/zhengcewenjian/2018-03-24/3152.html.
- 13. Campbell DT, Stanley JC. Experimental and quasi-experimental designs for research. Chicago IL: Rand McNally College, 963: 5-6.
- 14. Canadian Task Force on the Periodic Health Examination. The periodic health examination. CMAJ, 1979, 121(9): 1193-1254.
- 15. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength of recommendations. BMJ, 2004, 328(7454): 1490-1494.
- 16. Liao X, Robinson N. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety. Chin J Integr Med, 2013, 19(7): 494-497.
