Analysis of the implementation status and countermeasures of drug marketing authorization holder system in China
GAN Changjiao
CHENG Li
YUAN Yanfang
FANG Jun
Abstract：The Marketing Authorization Holder(MAH)system is the core and basic system throughout the Drug Administration Law of the People's Republic of China.To further leverage the role of the MAH system in optimizing resource allocation and implementing the primary responsibility of holders,institutional documents since the implementation of the MAH system in China has been summarized and organized.Based on the actual situation of China's pharmaceutical industry and its regulation,as well as drawing on international experience,targeted improvement suggestions are proposed.Such as strengthening the holders to perform their duties responsibly,exploring the establishment of a unified and independent cross-provincial regulatory mechanism and a third regulator,and improving the laws and regulations of the MAH system.
Keywords：Marketing Authorization Holder systemCommissioned productionDrug regulation
Publication Date：2024-05-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 449-454 )