Key Points and Common Problems in Review of Post-approval Filing Changes of Drugs Passed Quality and Efficacy Consistency Evaluation of Generic Drugs in Shandong Province
Objective To analyze the filing status of drugs that have passed Quality and Efficacy Consistency Evaluation of Generic Drugs in Shandong Province,so as to improve the filing quality and efficiency of change research conducted by marketing authorization holders.Methods The filing categories and contents of post-approval changes of drugs that have passed Quality and Efficacy Consistency Evaluation of Generic Drugs in Shandong Province in 2023 are summarized,and the common problems in the filing documents are analyzed and discussed based on the concern points of the technical review.Results and Conclusion Marketing authorization holders should strictly fulfill the holder's principal responsibility and carry out sufficient and comprehensive research and validation on post-approval changes of the drugs that have passed Quality and Efficacy Evaluation of Generic Drugs to ensure that the changes do not adversely affect the consistency of the quality and efficacy of the generic drugs.
generic drugquality and efficacy consistencyfiling documenttechnical reviewcommon problem
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