2012年292例化学药品说明书样稿问题分析

Problem analysis of 292 cases of chemical drug labeling drafts in 2012

收集2012年审核的注册报送的化学药品说明书样稿292例,分析其中存在的不符合我国法规要求的问题,对问题较多的医学项目逐项详细列举其存在的主要问题和具体品种。结果发现样稿普遍存在问题,很难找到一份完全符合法规要求的样稿,问题较多的医学项目包括警示语、药理毒理、用法用量、不良反应、药代动力学、注意事项和药物过量等。这种现状应引起说明书撰写者足够重视。注意提高药品说明书质量,保证终端用户安全有效用药。

This paper collected 292 cases of chemical drug labeling drafts submitted for the registration and audited in 2012,and analyzed the problems thereof not meeting the requirements of laws and regulations of China.There are problems universally in the drug labeling drafts and it is very difficult to find one to conform to the laws and regulations request completely.More problems of medicinal sections include warning,pharmacology and toxicology,dosage and administration,adverse reactions,pharmacokinetics,and overdosage.This situation should arouse the enough attention of drafters for drug labeling.Pay attention to improve the specification of drug labeling and to ensure the safe and effective medication of the end users.