Research on the preapproval inspections of FDA and the enlightenment to China
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.
NETL
NSTL
万方数据
