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is a major challenge to the development of PCM.At present,PCM instructions face legal regulation issues such as outdated legal norms,limited responsibilities of the marketing authorization holder(MAH)in writing instructions,and incomplete regulatory systems,resulting in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.
关键词
中成药说明书/法律规制现状/法律属性/说明义务/建议
Key words
proprietary Chinese medicine instructions/legal regulation status/legal attributes/obligation to state/proposals
维普
万方数据