目的：研究分析中药产品在巴西的上市监管政策，为中药在巴西上市提供参考。方法：采用文本研究和比较研究的方法，对巴西“关于中药产品制造和商业化的法规”(RDC 21/2014)开展分析，并结合“关于延长中药产品制造和商业化的法规的决定”(RDC 280/2019)以及“关于草药的注册和传统草药产品的注册通知”(RDC 26/2014)等法规进行比较分析。结果与结论：巴西对中药的使用和监管处于包容兼收的阶段，采用了有限制条件的宽松政策。建议我国药品监管部门和中医药研究机构加强中药监管、中药研究等领域的交流合作。
Objective: To study and analyze the regulatory policies for the listing of traditional Chinese medicine products in Brazil, and provide reference for the listing of traditional Chinese medicine products in Brazil. Methods: By using textual study and comparative research method, this article analyzed the ‘Regulations on the Manufacturing and Commercialization of Traditional Chinese Medicine Products’(RDC 21/2014) in Brazil, and compared it with the ‘Decision on the Extension of Regulations on the Manufacturing and Commercialization of Traditional Chinese Medicine Products’ (RDC 280/2019), and the ‘Notice on the Registration of Herbal Medicines and the Registration of Traditional Medicine Products" (RDC 26/2014). Results and Conculsion: Brazil is in the stage of inclusiveness in the use and supervision of traditional Chinese medicine, and has adopted restrictive and loose policies. It is suggested that drug regulatory authorities and traditional Chinese medicine research institutions strengthen exchanges and cooperation in the fi elds of traditional Chinese medicine supervision and research.
[1] 冯永刚.中医药的重要性及中药的现代化发展[C]//2012年中国药学大会暨第十二届中国药师周论文集,南京:2012:1516-1521.
[2] 吴传庆.美国植物药监管[R].北京国家中药科学监管大会,2022.
[3] 陈巧,马爱霞,潘勤.中成药如何进入欧盟市场[J].中国药事,2006,20(5):277-282.
[4] 秦洋.中医药在巴西[J].医药世界,2005(4):90.
[5] 张建武,邱琼.突破中药欧盟注册障碍的关键因素分析[J].中国中药杂志,2014,39(15):2972-2977.
[6] 李皓月,党迎迎,于涛,等.中医药在巴西的发展现状与分析[J].国际中医中药杂志,2021,43(5):429-434.
[7] Huynh-ba K,Beumer Sassi A.Anvisa:an Introduction toa New Regulatory Agency with Many Challenges [J].AAPSOpen,2018,4(1):9.
[8] ANIVISA.Resolu??o Da Diretoria Colegiada:RDC N°26De 13 De Maio De 2014[DB/OL].(2014-05-13)[2022-08-13].https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2014/rdc0026_13_05_2014.pdf.
[9] 赵浩如.论草药药品的基本特征及其注册类型[J].中国药事,2011,25(1):25-28.
[10] ANIVISA.Resolu??o Da Diretoria Colegiada:RDC N°21 De 25 De Abril De 2014[DB/OL].(2014-04-15)[2022-08-13].https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2014/rdc0021_25_04_2014.pdf.
[11] ANIVISA.Resolu??o Da Diretoria Colegiada:RDC N°280De 16 De Abril De 2019[DB/OL].(2019-04-16)[2022-08-13].https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2019/rdc0280_16_04_2019.pdf.
[12] 吴颖雄.新《药品管理法》中中药管理条款探析[J].中国卫生事业管理,2020,37(10):747-749.
[13] 张奇.世界卫生组织传统药监管合作[R].北京:国家中药科学监管大会,2022.
[14] 贺葵邦,李晓芳,白菊,等.2020年版《中国药典》一部中药外用制剂分析[J].中成药,2022,44(8):2645-2650.
[15] 徐昕怡.对中国药典国际协调的探讨和思考[J].中国药事,2019,33(12):1356-1364.
[16] 洪新昌.“一带一路”建设下中医药文化国际传播的困境与路径研究[D].哈尔滨:黑龙江中医药大学,2021.
