中美化学仿制药参比制剂选择与管理的对比及启示

Comparison of the selection and management of reference medicinal products of chemical generic drugs in China and America

参比制剂是仿制药研发的标杆和基础。本文介绍了我国化学仿制药参比制剂的遴选工作背景、遴选原则和路径,美国参比制剂的确定及管理模式,通过分析中美两国参比制剂选择管理的异同,为进一步完善我国参比制剂遴选及管理工作提供参考。

Reference medicinal products are benchmarks and foundations for the research and development of generic drugs.This article introduced the work background,principle,and path of the selection of reference medicinal products of chemical generic drugs in China,the identification and management status of reference listed drugs in America,compared and analyzed the differences in the selection of reference preparations in China and the United States,to provide references for further improving the selection and management of reference medicinal products in China.