中美原料药、药用辅料和药包材的注册管理对比研究

Comparative on the Registration Management of Active Pharmaceutical Ingredient,Pharmaceutical Excipient and Pharmaceutical Packaging Material between China and the United States

对中美两国原料药、药用辅料和药包材(以下简称“原辅包”)注册管理工作进行阐述和比较,包括政策和指导文件、产品适用范围和要求、登记(提交)和审查、变更和年报及关联审评程序等方面对比分析,旨在对我国原辅包注册管理工作的改进提供借鉴。

In order to put forward some suggestions on registration management in China,this paper made an systematically analysis&introduction on registration management of active pharmaceutical ingredient,pharmaceutical excipient and pharmaceutical packaging materials between China and the United States.The introduction includes relevant policies and guidance,application scope and corresponding requirement of product,registration(submission),review,change,annual reports and related evaluation procedures.