美国和欧盟基于替代终点的新药上市审批程序研究及启示

Research on the new drug marketing approval procedures based on surrogate endpoints in the US and EU and its enlightenment to China

近年来,应用替代终点来进行药物评价和监管决策已经成为提高药物研发效率的重要手段。美国和欧盟已经建立了较完善的基于替代终点的新药上市审批程序,替代终点在我国的新药上市审批中也发挥越来越重要的作用。本文从替代终点在新药上市审批中应用的原理入手,对美国和欧盟基于替代终点的新药上市审批程序进行深入研究,并对我国基于替代终点的新药上市审批程序的完善提出建议。

In recent years,using surrogate endpoints for drug evaluation and regulatory decision-making has become an important means to improve the efficiency of drug R&D.The United States and the European Union have established relatively completed new drug marketing approval procedures based on surrogate endpoints,and surrogate endpoints also play a more and more important role in China's new drug marketing approval procedure.This paper started with the principles of the application of surrogate endpoints in new drug marketing approval,made an in-depth study on the new drug approval procedures based on surrogate endpoints in the United States and the European Union,and put forward some suggestions on improving the new drug approval procedures based on surrogate endpoints in China.