Comparison and suggestions of food for special medical purposes in registration management system at home and broad

Authors

CHEN Hanqi, Hunan Agricultural University of Horticulture, Changsha, Hunan 410128, China;State Key Laboratory of Subhealth Intervention Technology, Changsha, Hunan 410128, China
LIU Min, The Third Xiangya Hospital of Central South University Nutritional Department, Changsha, Hunan 410013, China
YU Zhen, Hunan Agricultural University of Horticulture, Changsha, Hunan 410128, China;State Key Laboratory of Subhealth Intervention Technology, Changsha, Hunan 410128, China
HU Kun, Hunan Food Standardization Association, Changsha, Hunan 410013, China
CHEN Xuan, Hunan Agricultural University of Horticulture, Changsha, Hunan 410128, China;State Key Laboratory of Subhealth Intervention Technology, Changsha, Hunan 410128, China
LIU Dongbo, Hunan Agricultural University of Horticulture, Changsha, Hunan 410128, China;State Key Laboratory of Subhealth Intervention Technology, Changsha, Hunan 410128, China;Hunan Provincial Engineering Research Center of Medical Nutrition Intervention Technology for Metabolic Diseases, Changsha, Hunan 410128, ChinaFollow

Corresponding Author(s)

刘东波（1970—），男，湖南农业大学教授，博士。E-mail：chinasaga@163.com

Abstract

The registration management system of food for special medical purposes （FSMP） in China has been initially established. But compared with other developed countries, China's FSMP industry started late, and its system needs to be supplemented and improved. This research briefly describes the registration management mode of FSMP in our countries, analyzes the problems and challenges faced at present, sorts out the registration management system of FSMP in the European Union, the United States and Japan. Suggestions are put forward from three perspectives: product research and development, product access, and approval process, In order to provide more choices for people's health security and promote the sustainable development of China's FSMP industry.

Publication Date

12-26-2023

First Page

1

Last Page

6

DOI

10.13652/j.spjx.1003.5788.2023.60154

Recommended Citation

Hanqi, CHEN; Min, LIU; Zhen, YU; Kun, HU; Xuan, CHEN; and Dongbo, LIU (2023) "Comparison and suggestions of food for special medical purposes in registration management system at home and broad," Food and Machinery: Vol. 39: Iss. 11, Article 1.
DOI: 10.13652/j.spjx.1003.5788.2023.60154
Available at: https://www.ifoodmm.cn/journal/vol39/iss11/1

References

[1] 杨溢, 朱晓光. 特医食品现状综述[J]. 食品安全导刊, 2018（14）: 69-71. YANG Y, ZHU X G. Summary of current situation of food for special medical purpose[J]. China Food Safety, 2018（14）: 69-71.
[2] 李美英, 李雅慧, 姜雨, 等. 浅析我国特医食品监管概况[J]. 食品工业科技, 2016, 37（18）: 387-390. LI M Y, LI Y H, JIANG Y, et al. Analysis of the regulation of foods for special medical purpose in China[J]. Science and Technology of Food Industry, 2016, 37（18）: 387-390.
[3] 中国经济网. 我国批准特医产品七成来自境内, 行业发展面临四大挑战\. （2023-05-11） [2023-10-08]. http://www.ce.cn/cysc/yy/hydt/202305/11/t20230511_38542257.shtml. China Economic Net. Seventy percent of China's approved food for special medical purposes come from within the country, and the development of the industry faces four major challenges\. （2023-05-11） [2023-10-08]. http://www.ce.cn/cysc/yy/hydt/202305/11/t20230511_38542257.shtml.
[4] 王林智, 汪敏, 刘学武. 特殊医学用途配方食品的立法建议[J]. 食品与机械, 2017, 33（8）: 214-217. WANG L Z, WANG M, LIU X W. Legislative suggestions on formula foods for special medical purpose[J]. Food & Machinery, 2017, 33（8）: 214-217.
[5] 张斯, 曾绮莹, 莫锡乾, 等. 中国特医食品产业发展面临的机遇和挑战[J]. 现代食品, 2023, 29（7）: 42-45. ZHANG S, ZENG Q Y, MO X Q, et al. Opportunities and challenges faced by the development of industry on formula food for special medical purposes in China[J]. Modern Food, 2023, 29（7）: 42-45.
[6] 中华人民共和国国家卫生和计划生育委员会. 食品安全国家标准特医食品通则: GB 29922—2013[S]. 北京: 中国标准出版社, 2013: 1-12. National Health and Family Planning Commission, People's Republic of China. Food safety national standard foods for special medical purpose of general rules: GB 29922—2013[S]. Beijing: China Standard Press, 2013: 1-12.
[7] 揭良, 苏米亚. 特医食品的研究进展[J]. 食品工业, 2022, 43（1）: 259-262. JIE L, SU M Y. Progress in research and application of formulations for special medical purposes[J]. Food Industry, 2022, 43（1）: 259-262.
[8] 田洪芸, 解恒杰, 王冠群, 等. 国内外特殊医学用途配方食品标准概况及技术指标比对[J]. 中国乳品工业, 2019, 47（12）: 29-32, 43. TIAN H Y, XIE H J, WANG G Q, et al. General situation of food for special medical purpose standards at home and abroad and comparison of technical indicators[J]. China Dairy Industry, 2019, 47（12）: 29-32, 43.
[9] 殷杰, 石阳, 贝君, 等. 我国特殊食品法律法规和标准体系现状研究[J]. 食品安全质量检测学报, 2020, 11（19）: 7 123-7 129. YIN J, SHI Y, BEI J, et al. Study on the status of China's special food laws and regulations and standard system[J]. Journal of Food Safety and Quality, 2020, 11（19）: 7 123-7 129.
[10] 刘丽, 孙英. 2019年乳业新商机细分奶粉的美颜时代[J]. 乳品与人类, 2018（6）: 4-19. LIU L, SUN Y. 2019 New business opportunities in the dairy industry segmentation of milk powder beauty era[J]. Dairy and Human, 2018（6）: 4-19.
[11] 韦晓瑜, 聂大可. 关于特医食品注册管理制度实施的思考[J]. 中国食品卫生杂志, 2022, 34（6）: 1 286-1 290. WEI X Y, NIE D K. Some thoughts on the implementation of the registration management system of formula foods for special medical purposes[J]. Chinese Journal of Food Hygiene, 2022, 34（6）: 1 286-1 290.
[12] 中华人民共和国全国人民代表大会常务委员会. 中华人民共和国食品安全法: 主席令第二十一号[S]. 北京: 中国标准出版社, 2015: 16-18. Standing Committee of National People's Congress of the People's Republic of China. Food safety law of the people's republic of China: Order No. 21 of the President[S]. Beijing: China Standard Press, 2015: 16-18.
[13] 宁俊, 张茜, 王新明, 等. 国内外特医食品发展概况[J]. 生物产业技术, 2018（6）: 68-74. NING J, ZHANG Q, WANG X M, et al. Overview of the development of foods for special medical purposes at home and abroad[J]. Bioindustrial Technology, 2018（6）: 68-74.
[14] 王海燕. 新中国成立70周年我国特殊食品监管法规体系演变历程[J]. 中国食品药品监管, 2019（5）: 30-43. WANG H Y. 70th anniversary of the founding of New China, China's food for special medical purposes regulatory system evolution[J]. Chinese Food and Drug Regulation, 2019（5）: 30-43.
[15] 张葵, 车佩云. 我国特医食品营养功效调查[J]. 粮食科技与经济, 2019, 44（9）: 102-108. ZHANG K, CHE P Y. Investigation on nutritional efficacy of food for special medical purposes in our country[J]. Grain Deep Processing and Food, 2019, 44（9）: 102-108.
[16] 国家食品药品监督管理总局. 特医食品注册管理办法: 国家食品药品监督管理总局令第24号[S]. 北京: 中国标准出版社, 2016: 1-14. State Food and Drug Administration. Administrative measures for registration of food for special medical purposes: Order No. 24 of the State Food and Drug Administration[S]. Beijing: China Standard Press, 2016: 1-14.
[17] 国家食品药品监督管理总局. 总局关于发布《特医食品注册管理办法》相关配套文件的公告（2016年第123号） \. （2016-07-14） [2023-10-08]. http://www.cnhfa.org.cn/fagui/show.php?itemid=188. State Food and Drug Administration. Announcement of the General Administration on the release of the relevant supporting documents of the "food for special medical purposes Registration Management Measures" （No. 123 of 2016） \. （2016-07-14） [2023-10-08]. http://www.cnhfa.org.cn/fagui/show.php?itemid=188.
[18] 张立实, 李晓蒙. 我国特医食品的发展及其监管[J]. 中国食品卫生杂志, 2023, 35（2）: 151-155. ZHANG L S, LI X M. Development and supervision of food for special medical purpose （FSMP） in China[J]. Chinese Journal of Food Hygiene, 2023, 35（2）: 151-155.
[19] 王红太. 哈维药业特医食品江苏市场营销策略研究[D]. 兰州: 兰州大学, 2021: 59-60. WANG H T. Research on marketing strategy of food for special medical purpose of harvey pharmaceutical in Jiangsu province[D]. Lanzhou: Lanzhou University, 2021: 59-60.
[20] 韩军花. 中国特殊医学用途配方食品标准法规: 现状及展望[J]. 营养学报, 2017, 39（6）: 543-548. HAN J H. Standards and regulations on foods for special medical purposes in China: Current situations and prospects[J]. Journal of Nutrition, 2017, 39（6）: 543-548.
[21] 李湖中, 孙大发, 屈鹏峰, 等. 国内外特医食品法规标准与安全管理对比分析[J]. 中国食物与营养, 2020, 26（5）: 29-34, 56. LI X Z, SUN D F, QU P F, et al. Comparative analysis of regulations, standards and safety management of foods for special medical purposes at home and abroad[J]. Food and Nutrition in China, 2020, 26（5）: 29-34, 56.
[22] European Commission. Directive 1999/21/EC of the European Parliament and of the Council of 25 March 1999 on dietary foods for special medical purposes[S]. [S.l.]: Official Journal of the European Union, 1999: 29-33.
[23] Japan. Health Promotion Act: Law No. 103 of 2002[S]. [S.l.]: Ministry of Health, Labour and Welfare, 2002: 11-13.
[24] European Commission. Regulation （EU） No 2016/128 of 25 January 2016 amending Regulation （EU） No 10/2011 on plastic materials and articles intended to come into contact with food[S]. [S.l.]: Official Journal of the European Union, 2016: 1-4.
[25] 陶鑫. 浅谈美国医用食品（Medical Foods）的监管法规与市场准入[J]. 食品安全导刊, 2019（Z1）: 42-43. TAO X. The regulation and market access of medical foods in the United States[J]. China Food Safety, 2019（Z1）: 42-43.
[26] US Food and Drug Administration. Guidance for industry exempt infant formula production: Current good manufacturing practices （CGMPs）, quality control procedures, conduct of audits, and records and reports \. （2016-04-10） [2023-10-08]. http://www.fda.gov/FoodGuidances.
[27] 闫向竹, 刘恬佳, 赵宏宇, 等. 中药材在国内食品中的发展与应用[J]. 现代食品, 2019（1）: 57-58, 61. YAN X Z, LIU T J, ZHAO H Y, et al. Development and application of Chinese medicinal materials in domestic food[J]. Modern Food, 2019（1）: 57-58, 61.
[28] 周子琪, 苟茂琼, 胡雯, 等. 中国特殊医学用途配方食品行业现况及探索[J]. 肿瘤代谢与营养电子杂志, 2021, 8（4）: 439-444. ZHOU Z Q, GOU M Q, HU W, et al. Food for special medical purposes in China: Status quo and future development[J]. Electron J Metab Nutr Cancer, 2021, 8（4）: 439-444.
[29] 刘清扬, 刘鑫, 王少红, 等. 基于《第一批罕见病目录》的罕见病药物可及性研究[J/OL]. 协和医学杂志. （2023-08-23） [2023-10-08]. https://link.cnki.net/urlid/11.5882.R.20230823.1447.002. LIU Q Y, LIU X, WANG S H, et al. Research of accessibility of rare disease drugs based on the first rare disease catalogue[J/OL]. Medical Journal of Peking Union Medical College Hospital. （2023-08-23） [2023-10-08]. https://link.cnki.net/urlid/11.5882.R.20230823.1447.002.
[30] 孙艺航, 刘叔文. 我国罕见病诊疗与孤儿药的发展现状与路径[J]. 中国药理学通报, 2023, 39（4）: 601-605. SUN Y H, LIU S W. Development status and path of rare disease diagnosis and treatment and orphan drugs in China[J]. Chinese Pharmacological Bulletin, 2023, 39（4）: 601-605.
[31] 国家卫生健康委. 罕见病诊疗指南（2019年版）[S]. 北京: 中国标准出版社, 2019: 1-4. National Health Commission. Rare disease guidelines （2019 Edition）[S]. Beijing: China Standard Press, 2019: 1-4.
[32] Bened Life Inc. US-based biomedical company launches first medical probiotic targeting brain health\. （2022-08-03） [2023-08-28]. https://www.prweb.com/releases/US_Based_Biomedical_Company_Launches_First_Medical_Probiotic_Targeting_Brain_Health/prweb18812214.htm.
[33] WU Y N. 特医食品市场容量达百亿中国特医食品行业发展前景及需求分析\. （2022-03-29） [2023-10-08]. https://www.chinairn.com/news/20220329/175805905.shtml. WU Y N. Foods for special medical purposes market capacity of 10 billion China special medical food industry development prospects and demand analysis\. （2022-03-29） [2023-10-08]. https://www.chinairn.com/news/20220329/175805905.shtml.
[34] 搜狐网. 特医食品研发前沿动态\. （2017-05-11） [2023-10-08]. https://www.sohu.com/a/139720653_699050. Sohu. Foods for special medical purposes research and development frontier\. （2017-05-11） [2023-10-08]. https://www.sohu.com/a/139720653_699050.
[35] 国家食品药品监督管理总局. 特医食品临床试验质量管理规范（试行）解读\. （2016-11-01） [2023-10-08]. https://www.gov.cn/xinwen/2016-11/01/content_5127060.htm. State Food and Drug Administration. Foods for special medical purposes clinical trial quality management practice （trial） \. （2016-11-01） [2023-10-08]. https://www.gov.cn/xinwen/2016-11/01/content_5127060.htm.
[36] 李雅慧, 郭清伍. 特医食品临床试验质量管理规范（试行）解析[J]. 中国医刊, 2018, 53（1）: 17-21. LI Y H, GUO Q W. Interpretation of "food for special medical purpose clinical practice （Trial draft）"[J]. Chinese Journal of Medicine, 2018, 53（1）: 17-21.
[37] 陈彬合, 袁振海, 贾婵媛. 我国特医食品批准情况分析与开发建议[J]. 食品与药品, 2020, 22（4）: 294-300. CHEN B H, YUAN Z H, JIA C Y. Approval status analysis of formula food for special medical use in China and its development proposal[J]. Food and Drug, 2020, 22（4）: 294-300.
[38] 王海燕. 我国特殊食品注册（备案）要求比较分析[J]. 中国食品药品监管, 2018（1）: 46-51. WANG H Y. Comparative analysis of Food for special medical use registration （record） requirements in China[J]. Chinese Food and Drug Regulation, 2018（1）: 46-51.