关键词: font-size:medium, ">药品再注册；技术审查；常见问题；情况分析

Abstract: Starting from the regulatory system of drug re-registration after market launch in China, and taking time as the axis, this study systematically traces the evolution trajectory of the drug re-registration system in China from initial standardization to refined improvement, aiming to clarify the regulatory framework and dynamic adjustment process of drug re-registration management. Focusing on the actual situation of drug re-registration review in Hainan Province in recent years, this study takes the re-registration application materials submitted by holders within the jurisdiction as the research object, relies on the practical experience of regulatory authorities in reviewing, and combines with actual review cases to deeply analyze the common problems exposed in the re-registration technical review process, such as insufficient compliance of application materials and weak technical content. Based on these issues and the actual situation, reveal the underlying causes and propose improvement suggestions from multiple perspectives, including building an integrated drug information sharing platform, establishing linkage mechanism between evaluation and inspection, implementing graded and classified management of drug re-registration, and developing and promoting standardized declaration templates. This article aims to help drug marketing authorization holders standardize their declaration behavior, improving declaration efficiency, and providing reference for regulatory authorities to achieve scientific review and precise supervision.
 

Key words: font-size:medium, ">Drug re-registration； Technical review； Common problems； Situation analysis