Characteristics and insights of the European Medicines Agency guideline development
SUN Tan-lin
XU Zhen-yu
Abstract：This article delves into the characteristics of the European Medicines Agency(EMA)guidelines and their implications for China.Authers analyze the EMA's scientific,transparent,and collaborative regulatory model by exploring its development process,classification system,implementation transition period,and update mechanism.The EMA guidelines represent a comprehensive and multi-level framework that ensures alignment with current laws and global standards while effectively addressing risks associated with emergencies and technological advancements.Building on this foundation,this article proposes optimization suggestions for the guidelines of drug regulation in China,in order to further enhance the impact on the scientific rigor and credibility of drug regulation in China.
Keywords：drug regulationguidelineregulatory science
Publication Date：2025-07-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1368-1372 )