介紹我國國家食品藥品監(jiān)督管理總局(CFDA)、歐洲藥品管理局(EMA)和美國食品藥品管理局(FDA)對處方藥說明書[用法用量]項撰寫要點的要求,分析在我國注冊報送的說明書樣稿典型案例,包括進口藥和跨國公司在華藥廠的藥品說明書樣稿,揭示不符合上述要求和違背有效而安全用藥基本原則的表現(xiàn),期待對說明書撰寫和監(jiān)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.