Value of real world evidence for health food research & development and evaluation_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Jinbo ,  CHEN Guangyao

Food Review Center of State Administration for Market Regulation (National Review Committee on the protection of Chinese traditional Chinese Medicine), Beijing 100070, P.R.China;

Corresponding author：

CHEN Guangyao, Email: chenguangyao@bjsp.gov.cn

Keywords：

Real world study; Real world evidence; Health food; National drug administration

DOI：

10.7507/1672-2531.202005051

Video：

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In January 2020, the State Food and Drug Administration issued the guiding principles of real world evidence supporting drug research & development (R&D) and evaluation (Trial) to guide the development of real world study (RWS) for drug R&D and review decision-making in the future. This guideline has important reference value for developing RWS of health food. Based on the interpretation of the core content of the guiding principles, combined with the common points of RWS and health food interventions, this paper preliminarily discusses the application of RWS to support health food regulatory decision-making so as to provide references for further promoting the application of RWS in the field of health food.

Citation： WANG Jinbo, CHEN Guangyao. Value of real world evidence for health food research & development and evaluation. Chinese Journal of Evidence-Based Medicine, 2020, 20(10): 1130-1133. doi: 10.7507/1672-2531.202005051 Copy

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1. Botts RP, Edlavitch SA. Clinical evaluation of methods of treatment. Can J Comp Med Vet Sci, 1967, 31(2): 48-52.
2. Kaplan NM. The CARE Study: a postmarketing evaluation of ramipril in 11,100 patients. The Clinical Altace Real-World Efficacy (CARE) Investigators. Clin Ther, Jul-Aug, 1996, 18(4): 658-670.
3. CBO. H. R. 6-21^st century cures act, 2015-07-13. Available at: https://www.congress.gov/bill/114th-congress/house-bill/6.
4. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence - what is it and what can it tell us? N Engl J Med, 2016, 375(23): 2293-2297.
5. FDA. Use of real-world evidence to support regulatory decisions-making for medical devices: guidance for industry and food and drug administration staff, 2017-08-31. Available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf.
6. FDA. Framework for FDA’s real-world evidence program, 2018-11. Available at: https://www.fda.gov/media/120060/download.
7. FDA CDER, CBER. Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics. Guidance for industry, 2019-05. Available at: https://www.fda.gov/media/12479/download.
8. 戴亮, 季光. 基于 FDA《真实世界证据计划框架》论析真实世界研究对中药新药研发的意义. 中药新药与临床药理, 2019, 30(11): 1403-1408.
9. 金鑫瑶, 郑文科, 张俊华, 等. 推进真实世界研究的透明化. 世界中医药, 2019, 14(12): 3106-3110.
10. 孙鑫, 谭婧, 王雯, 等. 建立真实世界数据与研究技术规范, 促进中国真实世界证据的生产与使用. 中国循证医学杂志, 2019, 19(7): 755-762.
11. 宣建伟, 李幼平. 真实世界研究与创新药物价值. 中国循证医学杂志, 2018, 18(4): 273-276.
12. 孙鑫, 谭婧, 唐立, 等. 基于真实世界证据的上市后药品评价技术框架体系: 思考与建议. 中国循证医学杂志, 2018, 18(4): 277-283.
13. 国家药品监督管理局. 关于发布真实世界证据支持药物研发与审评的指导原则(试行)的通告(2020年第1号), 2020-1-3. Available at: http://www.nmpa.gov.cn/WS04/CL2138/373175.html.
14. 中华人民共和国国家卫生和计划生育委员会. 食品安全国家标准保健食品: GB16740-2014. 北京: 中国标准出版社, 2014.
15. 王进博, 陈广耀. 基于中医和法学对保健食品功能声称和证明标准的思考与建议. 中华中医药杂志, 2019, 34(12): 5782-5784.
16. 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.
17. 国家中医药管理局. 关于发布《古代经典名方目录(第一批)》的通知, 2018-04-16. Available at: http://kjs.satcm.gov.cn/zhengcewenjian/2018-04-16/7107.html.
18. 王进博, 陈广耀, 孙蓉, 等. 对中药组方保健食品的几点思考. 中国中药杂志, 2019, 44(5): 865-869.
19. 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.

Chinese Journal of Evidence-Based Medicine

Value of real world evidence for health food research & development and evaluation

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