美国FDA批准前检查的分析与启示

Research on the preapproval inspections of FDA and the enlightenment to China

通过收集美国FDA网站公布的批准前检查相关法律法规,研究美国FDA药品批准前检查(preapproval inspection,PAI)的发展历程,重点对美国FDA药品批准前检查合规项目手册及其修订过程进行分析讨论。美国FDA基于风险和科学逐步完善批准前检查合规项目手册,以确保上市产品的安全有效和质量可控。建议在进行药品注册现场核查时,可从全生命周期的考量出发,确定核查要点,同时强化风险管理意识,加强交流和协作,提升药品注册核查的质量和效率。

This article studied the historical evolution of preapproval inspections(PAI)and the laws and regulations related to drug preapproval inspection published on the FDA website,focusing on analyzing the PAI compliance program guidance manual and discussing its development and revisions.Based on the risks and science,FDA gradually improved and completed the PAI compliance program guidance manual to ensure the safety,efficacy and quality control of drugs.It is suggested that PAI focus on the pharmaceutical product lifecycle management,enrich inspection tools,strengthen the consciousness of risk management,increase the communication and collaboration,and improve the quality of drug registration inspection and the ability of risk resistance.