湖北省已上市化学药品变更有效期和贮藏条件备案申报资料常见问题分析及建议

Analysis and suggestions on common problems of filing and application materials for the change of validity period and storage conditions of listed chemical drugs in Hubei Province

目的:研究湖北省已上市化学药品变更有效期和贮藏条件备案申报资料审查及发补中的常见问题,为药品上市许可持有人(MAH)变更产品有效期和贮藏条件和提高产品质量提供参考。方法:以已上市化学药品MAH通过国家药品监督管理局药品业务应用系统提交的变更备案资料为研究对象,采用汇总归纳的方法对备案资料中审评和发补中的常见问题进行分析总结。结果:MAH的变更有效期和贮藏条件备案资料完整性、变更原因合理性、稳定性试验方案制定、试验条件选择、考察指标、数据完整性等方面还存在不足和问题。结论:MAH应深入学习新法规及指导原则、加强与审评监管机构沟通,准确把握上市后变更备案的申报要求,切实履行自身的主体责任,确保备案资料的真实、完整和可追溯。

Objective:To study the common problems in the review and supplement of the filing data of the validity period and storage conditions of the listed chemical drugs in Hubei Province,and to provide references for the drug marketing authorization holders(MAH)to change the validity period and storage conditions of the products and improve the product quality.Methods:Taking the change record data submitted by the MAH of listed chemical drugs through the drug business application system of the National Medical Products Administration as the research object,the common problems in the review and supplement of the record data were analyzed and summarized by the method of summary and induction.Results:The integrity of the record data of the change of validity period and storage conditions of the MAH,the rationality of the change reasons,the formulation of the stability test plan,the selection of test conditions,the inspection indicator,the data integrity and other aspects of the deficiencies and problems still exist.Conclusion:MAH should study the new regulations and guiding principles in depth,strengthen communication with review regulators,accurately capture the requirements for post-listing filing data changes,and effectively fulfil their own responsibilities to ensure the truthfulness,completeness and traceability of the filing data.