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
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.
changes of the validity period and storage conditionspost approval changesapplication material
万方数据
维普
