| 袁博,苏辅芸,卢忠,莫结丽,姚立新,吴桂萍.中药产品在巴西上市监管法规分析及对我国的启示[J].中国药事,2023,(5):583-587 |
| 中药产品在巴西上市监管法规分析及对我国的启示 |
| Analysis of the Listing and Regulatory Policy for Traditional Chinese Medicine Products in Brazil and the Enlightenment for China |
| 投稿时间：2022-08-15 |
| DOI：10.16153/j.1002-7777.2023.05.012 |
| 中文关键词: 巴西 中药 政策 协调 上市 |
| 英文关键词: Brazil traditional Chinese medicine policy coordinate listing |
| 基金项目:2021年国家药品监督管理局政策研究课题，广州市哲学社科规划2022年度课题(编号 2022GZJ42) |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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