摘要
仿制药一致性评价是药品注册整体改革中的核心环节,本文结合我国、日本与美国的仿制药一致性评价研究要求和监管法规,比较分析了评价对象的选择,概述参比制剂的选择和确定,比较了评价方法的不同,并综述了各国生物等效性豁免的政策,以供我国仿制药有关企业和监管部门参考,此次仿制药质量一致性评价为建立我国药品参比制剂目录提供了契机,为整体提升中国仿制药质量提供一次历史性机遇。
Consistency evaluation of generic drugs is the critical step in drug registration revolution. Based on the research requirements and regulation in China, Japan and the United States on the consistency evaluation of generic drugs, this paper compares the selection of objects in consistency evaluation, analyzes the choice of reference products, and summarizes the differences in evaluation methods, and principles of waiving policy on the bioavailability of generic drugs in various countries. We help to provide a reference for relevant enterprises and regulatory authorities concerning generic drugs in China. The quality consistency evaluation of generic drugs provides an opportunity for the establishment of China＇s Reference List for generic drugs and improvement in the quality of generic drugs in China.
作者
苏娴
高云佳
SU Xian;GAO Yun-jia(Center of Drug Evalution,China Food and Drug Administration,Beijing 100022;Modern Research Center of Traditional Chinese Medicine,Health Science Center,Peking University,Beijing 100191)
出处
《中南药学》
CAS
2018年第9期1339-1342,共4页
Central South Pharmacy
关键词
一致性评价
参比制剂
溶出方法
generic consistency evaluation
reference product
dissolution
