Introduction of common deficiencies and issues in CMC review of generic drugs
ZHANG Junlin
WANG Shaorong
WANG Shuhua
Abstract：Regulatory agencies in various countries have issued a series of documents on common deficiencies and issues to improve the efficiency of generic drug review,which play an important role in standardizing and improving the quality of filing information.This paper intends to summarize the guidelines or technical documents that have been issued by FDA,EMA and NMPA related to the improvement of the quality of the declaration information,and introduce the common issues related to the pharmacy technical review of the generic drug declarations therein,in the hope that it can provide a glimpse of the high-quality development and reform of China's generic drugs.
Keywords：Generic drugsCommon deficiencies and issuesHigh-quality developmentDrug review
Publication Date：2024-10-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 972-978 )