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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17.	國家中醫藥管理局. 關于發布《古代經典名方目錄(第一批)》的通知, 2018-04-16. Available at: http://kjs.satcm.gov.cn/zhengcewenjian/2018-04-16/7107.html.
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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《真實世界證據計劃框架》論析真實世界研究對中藥新藥研發的意義. 中藥新藥與臨床藥理, 2019, 30(11): 1403-1408.
9. 金鑫瑤, 鄭文科, 張俊華, 等. 推進真實世界研究的透明化. 世界中醫藥, 2019, 14(12): 3106-3110.
10. 孫鑫, 譚婧, 王雯, 等. 建立真實世界數據與研究技術規范, 促進中國真實世界證據的生產與使用. 中國循證醫學雜志, 2019, 19(7): 755-762.
11. 宣建偉, 李幼平. 真實世界研究與創新藥物價值. 中國循證醫學雜志, 2018, 18(4): 273-276.
12. 孫鑫, 譚婧, 唐立, 等. 基于真實世界證據的上市后藥品評價技術框架體系: 思考與建議. 中國循證醫學雜志, 2018, 18(4): 277-283.
13. 國家藥品監督管理局. 關于發布真實世界證據支持藥物研發與審評的指導原則(試行)的通告(2020年第1號), 2020-1-3. Available at: http://www.nmpa.gov.cn/WS04/CL2138/373175.html.
14. 中華人民共和國國家衛生和計劃生育委員會. 食品安全國家標準保健食品: GB16740-2014. 北京: 中國標準出版社, 2014.
15. 王進博, 陳廣耀. 基于中醫和法學對保健食品功能聲稱和證明標準的思考與建議. 中華中醫藥雜志, 2019, 34(12): 5782-5784.
16. 衛生部. 關于進一步規范保健食品原料管理的通知(衛法監發﹝2002﹞51 號), 2002-2-28. Available at: http://www.eshian.com/laws/10461.html.
17. 國家中醫藥管理局. 關于發布《古代經典名方目錄(第一批)》的通知, 2018-04-16. Available at: http://kjs.satcm.gov.cn/zhengcewenjian/2018-04-16/7107.html.
18. 王進博, 陳廣耀, 孫蓉, 等. 對中藥組方保健食品的幾點思考. 中國中藥雜志, 2019, 44(5): 865-869.
19. 國家市場監督管理總局. 保健食品原料目錄與保健功能目錄管理辦法(國家市場監督管理總局令第13號), 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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