摘要
随着药品审评审批制度改革的不断深入,仿制药一致性评价工作已全面开展,其中参比制剂选择与确定是制约一致性评价工作进展的因素之一,本文通过翻译转化,详细地介绍了美国ANDA申报参照药品行业指南草案,以期为我国仿制药一致性评价工作中参比制剂遴选提供参考依据。
With the continuous deepening the reform of the review ＆ approval System for drugs, the evaluation of generic drug conformity has been carried out in an all-round way. Among them,the selection and determination of reference Listed drug are one of the factors restricting the progress of conformity assessment. This paper Introduces of The Guidance for Industry of Referencing Approved Drug Products in ANDA Submissions in detail through translation and transformation, which provides reference for the selection of reference Listed drug in the evaluation of the conformity of generic drugs in our country.
作者
马玲云
萧红街
关皓月
孙慧姝
许鸣镝
MA Lingyun;XIAO Hongjie;Guan Haoyue;SUN Huishu;XU Mingdi(National Institutes for Food and Drug Control,Beijing 100050,China;Center for Certification and Evaluation of Guangdong Food and Drug Administration,Guangdong Guangzhou 510080,China)
出处
《中国药物评价》
2018年第2期141-147,共7页
Chinese Journal of Drug Evaluation
基金
国家"重大新药创制"科技重大专项资助项目(2017ZX09101001)
关键词
美国ANDA申报
仿制药一致性评价
参照药品
参比制剂
标准制剂
ANDA Submissions
Generic drug conformance evaluation
Reference drugs
Reference Listed drug
Reference standard
