摘要
从20世纪70年代起,中药/天然药物以其独特的治疗理念又重新受到推崇。欧美等发达国家在肯定植物药对疾病有预防和治疗作用的同时,也灵活调整了药品的监管方向,愿意以科学的态度重新对植物药进行系统评价,再次逐步接纳其作为治疗性产品。作者通过分析欧盟、美国和加拿大对植物药监管的历史和法规要求的异同,从国际药政的角度,提出中药未来可能的国际研发方向。
Because of the unique nature and treatment concept of traditional Chinese medicines （ TCMs）, TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries （ the FDA, EMA and Health Canada etc） have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global rezulatorv affairs.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2011年第19期2747-2750,共4页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2010ZX09401-06)
关键词
国际化
中药
植物药
传统草药
质量标准
安全性
有效性
internationalization
traditional Chinese medicine
botanical products
traditional herbal medicinal products
作者简介
[通信作者]孙鹤，Tel：（022）86345289，E-mail：henrysunusa@gmail．com
