中国临床药理学杂志
中國臨床藥理學雜誌
중국림상약이학잡지
The Chinese Journal of Clinical Pharmacology
2015年
16期
1687-1691
,共5页
抗菌药%说明书%分析
抗菌藥%說明書%分析
항균약%설명서%분석
antibacterial drug%labeling%analysis
本文主要根据我国相关法规、指导原则和专业知识并参考美国食品药品监督管理局的要求，分析近年注册申报的46例抗菌药说明书样稿存在的问题并列举典型实例，希望对提高我国抗菌药说明书质量有益。
本文主要根據我國相關法規、指導原則和專業知識併參攷美國食品藥品鑑督管理跼的要求，分析近年註冊申報的46例抗菌藥說明書樣稿存在的問題併列舉典型實例，希望對提高我國抗菌藥說明書質量有益。
본문주요근거아국상관법규、지도원칙화전업지식병삼고미국식품약품감독관리국적요구，분석근년주책신보적46례항균약설명서양고존재적문제병열거전형실례，희망대제고아국항균약설명서질량유익。
Fourty -six drafts of labeling for antibacterial drug sent for registration in recent years were analyzed mainly according to our country regulations,guidance and the specialized knowledge as well as referring to Food and Drug Administration of request, aiming to reveal problems and enumerated the typical examples, which was hope to be beneficial to improve the quality of labeling for antibacterial drug.
