从技术审评角度对中国药品说明书存在问题的思考

摘要

Drug labeling information is the legal and authorized information to guide the drug prescription precisely and medication safely. Although the drug regulatory agencies have highly awareness on the integrity of drug information and are pursuing the standardization of drug labeling for the public, it still have considerable issues existed. To address this concern from the technical reviewing perspective, we had conducted a survey by reviewing about 120 registering drug labels with either chemical drugs or biological products in China. The results have indicated those existed problems in current drug labeling in China.%药品说明书的信息直接关系到安全、合理使用药品.药品说明书指导医生开具处方和患者用药,其是具有法律效力的文本.药品说明书信息的重要性日益受到重视.因此,药品说明书的规范化已经成为我国药品管理的现实要求.本文从说明书技术审评的角度,通过对中国化学药品和生物制品说明书的调查以及存在问题的分析,为进一步完善药品说明书提供启发和借鉴.