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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。
Since the 1970s, Chinese medicine / natural medicine has been respected for its unique therapeutic concept. The developed countries such as Europe and the United States, while affirming the role of plant medicine in preventing and treating diseases, have also flexibly adjusted the regulatory direction of the drugs and are willing to re-evaluate the botanical drugs in a scientific manner and gradually accept it as a therapeutic product again. By analyzing the similarities and differences between the EU, the United States and Canada on the history and regulatory requirements for the regulation of botanical drugs, the author proposes the possible international R & D directions for the future of traditional Chinese medicine from the perspective of international pharmaceutical administration.