Research on the Current Legal Regulation Status and Strategies of Proprietary Chinese Medicines Instructions
The non-standard writing of proprietary Chinese medicine(PCM)instructions is a major challenge to the development of PCM.At present,PCM instructions face legal regulation issues such as outdated legal norms,limited responsibilities of the marketing authorization holder(MAH)in writing instructions,and incomplete regulatory systems,resulting in compromised patient rights and drug safety.This article starts from PCM instructions,analyzes its particularity from the legal perspective,analyzes and interprets the legal attributes of PCM instructions,and puts forward reasonable suggestions for improving the legal regulation of PCM,so as to provide a standardized guarantee for the sustainable development of PCM.
proprietary Chinese medicine instructionslegal regulation statuslegal attributesobligation to stateproposals
万方数据
维普
