院内中药制剂的价值与规制路径

The value and regulation of traditional Chinese medicine in hospital

通过满足患者需求出发论证院内中药制剂的存在价值,着重维护患者权益及用药安全,从院内中药制剂的准入机制、质量监控及不良反应监测、药品责任梳理现行法律及行政法规,在《中医药法》《药品管理法》的立法框架内探索、设计针对院内中药制剂的法律规制路径。

First of all,from the perspective of meeting the needs of patients to demonstrate the existence value of Traditional Chinese Medicine in hospital,and then from the perspective of safeguarding the rights and interests of patients and drug safety,this paper sorted out the content of current laws and administrative regulations from the access mechanism,quality monitoring,adverse reaction monitoring and drug responsibility.This paper also exploreed in the legislative framework of Traditional Chinese Medicine Law and the new Drug Management Law,and designed the legal regulation path for the Traditional Chinese Medicine preparation in the hospital.