美国食品和药物管理局生物标志物资格认定程序及其实施情况

U.S. Food and Drug Administration biomarker qualification program and its implementation

生物标志物是药物研发阶段的新型工具之一, 2008年美国食品和药物管理局(FDA)通过第一批肾脏生物标志物的安全性评估,允许其在药物研发中公开使用。此后, FDA逐步建立资格认定程序对生物标志物进行管理。本文通过参考FDA相关法规与指南,分析FDA生物标志物的资格认定程序及其实施情况,为我国药品监管部门结合创新药物研发需求、逐步探索并建立生物标志物管理程序提供参考。

Biomarkers are one of the new tools in the drug development phase.The U.S.Food and Drug Administration (FDA)approved the safety of the first kidney biomarkers,which were allowed to be used publicly during drug development in 2008.Since then,FDA has gradually established qualification program to manage biomarkers.This article referred to the relevant regulations and guidelines of FDA,analyzed the FDA biomarker qualification program and its implementation,and provided reference for China's drug regulatory departments to combine innovative drug research and development needs,and gradually explore and establish biomarker management programs.