处方药说明书[用法用量]项的撰写要点和案例分析

Writing highlights and case analysis of dosage and administration section of labeling for prescription drugs

介绍我国国家食品药品监督管理总局(CFDA)、欧洲药品管理局(EMA)和美国食品药品管理局(FDA)对处方药说明书[用法用量]项撰写要点的要求,分析在我国注册报送的说明书样稿典型案例,包括进口药和跨国公司在华药厂的药品说明书样稿,揭示不符合上述要求和违背有效而安全用药基本原则的表现,期待对说明书撰写和监管有益。

The writing highlights of dosage and administration section of labeling for prescription drugs required by China Food and Drug Administration （CFDA）, European Medicines Agency （EMA）, and Food ＆ Drug Administration （FDA） are described. The typical cases of labeling drafts submitted for drug marketing in our country are analyzed, including the labeling drafts of import drugs and Multi-National Corporation＇s products, in order to reveal the manifestations that do not meet the above regulatory requirements and violate the basic principles for effective and safe medication. The paper is expected to be useful to the writing and supervising of drug＇s labeling.