美国FDA《仿制药审评质量管理规范》简介及相关思考

Introduction to the U.S.FDA's“Good Abbreviated New Drug Application Assessment Practices”and reflections thereof

美国FDA近年来为加快仿制药批准上市出台了一系列政策性文件。本文对其中一个文件《仿制药审评质量管理规范》的相关内容进行介绍,以说明美国FDA如何设法从监管部门内部想办法,规范仿制药审评流程并提高审评效率和有效性,促进仿制药在不降低审评标准的前提下及早上市,并结合近年来我国药品审评审批制度改革出台的相关政策提出一些思考。

The U.S.Food and Drug Administration(FDA)has issued a series of policy documents in recent years to accelerate the approval and marketing of generic drugs.This article briefly introduced the relevant contents of one of these documents,i.e.,“Good Abbreviated New Drug Application Assessment Practices”,to explain how the US FDA tries to find a way,from the agency's perspective,to standardize the review process of generic drugs,and improve the review efficiency and effectiveness to promote generic drug marketing without quality compromising.Also,some thoughts were put forward respecting the relevant policies for the reform of China's drug review and approval system.