摘要
目的分析中药及天然药物的药物警戒发展,为中药及天然药物的药物警戒体系建设提供借鉴。方法查阅国内外文献,检索欧美英、大洋洲、亚洲国家和地区的中药及天然药物相关法律法规及指南规范,浏览其药品监管机构官方网站,分析其中药及天然药物的药物警戒监管机构设置、职责和法规内容等。结果中药及天然药物的药物警戒工作在各国家和地区药物警戒系统中均有涉及,欧盟、印度等国家和地区围绕中药及天然药物已建立相关监管机构及颁布了具体的法律法规,但中药及天然药物的药物警戒体系仍需建设。结论中药及天然药物的药物警戒已成为各国家和地区药物警戒体系中的重要组成部分,相较于其他国家和地区我国中药及天然药物的药物警戒体系相对完善,应协同各国家和地区相关药物警戒的发展,推动中药及天然药药物警戒持续研究,为健全全球中药及天然药物的药物警戒体系提供参考。
Objective To provide reference for the construction of pharmacovigilance systems of traditional Chinese medicine(TCM) and natural medicines by analyzing the development of pharmacovigilance of TCM and natural medicines. Methods Domestic and foreign literature was searched. Laws, regulations and guidelines related to TCM and natural medicines in some countries and regions were retrieved, the official websites of drug regulatory agencies were browsed, and pharmacovigilance regulatory agencies, related responsibilities, and regulatory content of TCM and natural medicines in various countries and regions were analyzed. Results Pharmacovigilance of TCM and natural medicines was specified in the pharmacovigilance system in many countries and regions. The European Union, India and other countries had established related regulatory agencies and worked out specific regulatory documents for TCM and natural medicines, but related pharmacovigilance systems were still under construction. Conclusion The pharmacovigilance of TCM and natural medicines has become an important part of pharmacovigilance in various countries and regions. The pharmacovigilance system of TCM and natural medicines in China is relatively complete compared with other countries and regions. China should keep up with the development of pharmacovigilance in various countries to motivate sustained research on pharmacovigilance of TCM and natural medicines and boost the development of global pharmacovigilance systems of TCM and natural medicines.
作者
吴昊
张冰
林志健
张晓朦
WU Hao;ZHANG Bing;LIN Zhijian;ZHANG Xiaomeng(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China;Center for Pharmacovigilance and Rational Use of Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China)
出处
《中国药物警戒》
2021年第5期406-410,421,共6页
Chinese Journal of Pharmacovigilance
基金
国家自然科学基金项目(81874349)
第三批国家高层次人才特殊支持计划(万人计划)教学名师项目
国家中医药领军人才支持计划“岐黄学者”项目
中国毒理学会临床毒理专项课题(CST2020CT501)。
关键词
国际
药物警戒
欧洲
美国
英国
大洋洲
亚洲
中药
天然药物
international
pharmacovigilance
European
American
natural medicines
United Kingdom
Oceania
Asian
traditional Chinese medicine(TCM)
