欧盟药品注册、企业生产许可证及GMP检查的相互关系

Relationship Among Drug Marketing Authorization,Manufacturing Authorization as Well as GMP Inspection

目的探讨当前形势下我国药事管理改革的措施。方法研究ICH近年颁布的Q系列文件,并结合欧盟药品注册、GMP检查、制药企业生产许可证管理等药事管理法规与规定,讨论欧盟药品注册、企业生产许可证及GMP检查的若干相互关系。结果与结论欧盟药品监管体系成熟,其某些举措可供我国药事管理制度改革时参考。

Objective To discuss reformation measures of Chinese administration of pharmaceutical affair in current situation.Methods The Q series guidelines published by ICH recently were studied.The rules and regulations governing medicinal products in European Union,some topics of the relationship among approval of drug marketing authorization,management of manufacturing authorization as well as GMP inspection within European Union were discussed.Results and Conclusions The system of European drug administration is well developed and efficient. Some aspects of the system may use as referenee and are valuable for the reformation of Chinese administration of pharmaceutical affair.