[1]张昕,陈焕鑫,卓清缘,等.中药产品在加纳的监管体系与注册路径研究[J].国际中医中药杂志,2022,44(04):366-370.[doi:10.3760/cma.j.cn115398-20210903-00036]
　Zhang Xin,Chen Huanxin,Zhuo Qingyuan,et al.Research on the regulation system and registration path of Traditional Chinese Medicine products in Ghana[J].,2022,44(04):366-370.[doi:10.3760/cma.j.cn115398-20210903-00036]

点击复制

中药产品在加纳的监管体系与注册路径研究

《国际中医中药杂志》[ISSN:1673-4246/CN:CN11-5398/R] 卷: 44 期数: 2022年第04期页码: 366-370 栏目: 中医药国际交流出版日期: 2022-04-08

Title:: Research on the regulation system and registration path of Traditional Chinese Medicine products in Ghana

作者:: 张昕1 2 ; 陈焕鑫2 3 ; 卓清缘4 ; 高展旺5; 王羚郦2 6; 1广州中医药大学中药学院2020级博士研究生,广州 510006 ;2东莞广州中医药大学研究院,东莞 523808 ;3广州中医药大学研究生院2018级硕士研究生,广州 510006 ;4广州中医药大学中药学院2019级硕士研究生,广州 510006 ;5广州中医药大学中药学院2020级硕士研究生,广州 510006 ;6广州中医药大学中药学院,广州 510006?/html>

Author(s):: Zhang Xin1 2; Chen Huanxin2 3; Zhuo Qingyuan 4; Gao Zhanwang5; Wang Lingli2 6; 1 Doctoral Degree Student of Grade 2020, Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, Guangzhou 510006, China; 2 Dongguan Guangzhou University of Chinese Medicine Institute, Dongguan 523808, China; 3 Master Degree Student of Grade 2018, Graduate School, Guangzhou University of Chinese Medicine, Guangzhou 510006, China; 4 Master Degree Student of Grade 2019, Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, Guangzhou 510006, China; 5 Master Degree Student of Grade 2020, Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, Guangzhou 510006, China; 6 Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, Guangzhou 510006, China

关键词:: 加纳; 中药产品; 注册; 策略

DOI:: 10.3760/cma.j.cn115398-20210903-00036

摘要:: 加纳重视对传统医药的利用，多年来陆续出台关于传统医药的法律及政策措施，为草药产品研发、注册与销售奠定了良好的法律基础。本文简述加纳草药与食品补充剂监管体系，梳理中药产品以草药和食品补充剂等不同类型在加纳注册的路径，并通过简要分析注册资料，认为中药产品可首先作为食品补充剂打开加纳市场，从而推进草药注册；需把控中药产品注册风险，同时强化中国与加纳的政府间合作；还需发挥中医药理论与经验优势，加强与加纳传统医药的合作。本文为中药产品在加纳注册上市提供参考，以期扩大中药在当地的市场，进而辐射至西非乃至整个非洲地区。

参考文献/References:

[1] The African Statistical Yearbook 2020[EB/OL]. (2021-01-12) [2021-06-01]. https://www.afdb.org/en/documents/african-statistical-yearbook -2020.

[2] van Andel T,Myren B,van Onselen S. Ghana’s herbal market[J]. J Ethnopharmacol, 2012,140(2):368-378. DOI: 10.1016/j.jep.2012.01.028.

[3] Kwame A. Integrating Traditional Medicine and Healing into the Ghanaian Mainstream Health System: Voices Fr om Within[J]. Qual Health Res ,2021,31(10):1847-1860. DOI:10.1177/10497323211008849.

[4] Obu RN,Bluwey LA. A Case Study of Complementary Alternative Medicines in Primary Healthcare in Ghana[J]. JOCAMR,2021,15(1):23-33. DOI:10.9734/JOCAMR/2021/v15i130256.

[5] Kpobi L,Swartz L. Indigenous and faith healing in Ghana: A brief examination of the formalising process and collaborative efforts with the biomedical health system[J]. Afr J Prim Health Care Fam Med, 2019 ,11(1):e1-e5. DOI: 10.4102/phcfm.v11i1.2035.

[6] Public Health Act,2012[EB/OL]. (2012-10-09)[2021-04-10]. https://fdaghana.gov.gh/img/annualrep/fdaact2020.pdf.

[7] Food And Drugs Authority 2017 Annual Report [EB/OL]. (2018-07-01)[2021-07-12]. https://fdaghana.gov.gh/img/annualrep/2017%20Annual%20Report.pdf.

[8] Baxerres C,Cassier M. Understanding Pharmaceutical Markets:An Analysis of Medicines, Regulations and Health Systems in the Global South[M]. Oxford:Taylor and Francis,2021:22-28.

[9] Guideline for Registration of Herbal Medicinal Products in Ghana[EB/OL]. (2013-02-01)[2021-04-10]. https://fdaghana.gov.gh/img/organisation/GUIDELINE%20FOR%20REGISTRATION%20OF%20HERBAL%20MEDICINAL-%20PRODUCTS(1).pdf.

[10] Guideline for Registration of Food/Nutritional/Dietary Supplements[EB/OL]. (2013-02-01)[2021-04-10]. https://fdaghana.gov.gh/img/organisation/GUIDELINES%20FOR%20THE%20REGISTRATION%20OF%20FOOD,%20NUTRITIONAL%20OR%20DIETARY%20SUPPLEMENTS.pdf.

[11] Amoah S,Sandjo LP,Bazzo ML,et al. Herbalists, traditional healers and pharmacists:a view of the tubercu losis in Ghana[J]. Revista Brasileira De Farmacognosia ,2014,24(1):89-95. DOI:10.1590/0102-695X2014241405.

[12] Boadu AA,Asase A. Documentation of Herbal Medicines Used for the Treatment and Management of Human Diseases by Some Communities in Southern Ghan a[J]. Evid Based Complement Alternat Med ,2017(11-12):1-12. DOI:10.1155/2017/3043061.

[13] 对外投资合作国别(地区)指南-加纳[EB/OL]. (2020-12-01) [2021-08-01]. http://fec.mofcom.gov.cn/article/gbdqzn/#.

相似文献/References:

[1]陈焕鑫张昕卓清缘高展旺王羚郦.中药产品在南非的注册路径与策略研究[J].国际中医中药杂志,2022,44(05):493.[doi:10.3760/cma.j.cn115398-20210510-00081]
　Chen Huanxin,Zhang Xin,Zhuo Qingyuan,et al.Research on the registration path and strategy of Traditional Chinese Medicine products in South Africa[J].,2022,44(04):493.[doi:10.3760/cma.j.cn115398-20210510-00081]
[2]曹海明,刘彤,许文静,等.中药产品在瑞典的注册路径分析与建议[J].国际中医中药杂志,2022,44(06):606.[doi:10.3760/cma.j.cn115398-20210509-00068]
　Cao Haiming,Liu Tong,Xu Wenjing,et al.Analysis and suggestions on the registration path of Traditional Chinese Medicine products in Sweden[J].,2022,44(04):606.[doi:10.3760/cma.j.cn115398-20210509-00068]

备注/Memo

基金项目：国家重点研发计划（2017YFC1703701）；广东省中医药服务与产业发展研究中心项目（2021YJZX007）

更新日期/Last Update:

2022-04-18