关键词: font-size:medium, ">药品上市许可持有人；中国国情；跨境持有与生产；分段生产

Abstract: The marketing authorization holder(MAH) system is the core and basic system in the Drug Administration Law. In the implementation of the MAH system， based on national conditions in China， some exploration and “flexible” practices have been gradually formed. For example， the entrust party for production(the marketing authorization holders)should have the approved license(s)for drug manufacture and implement dual release management of market release and production release， and regulatory authorities are required to strengthen administrative guidance， formulate quality and commission agreements， and implement the first responsibility system. In addition， there are also some restrictive measures， such as dividing the types of MAH by country and implementing conditional divided manufacturing. It is believed that with the continuous improvement of laws and regulations， the continuous improvement of the contract spirit of relevant subjects， the continuous improvement of the fault tolerance and correction mechanism of the whole society and the continuous improvement of the accountability environment， the MAH system will play a greater role in optimizing the allocation of market resources and promoting the sustainable and healthy development of the industry.

Key words: font-size:medium, ">Marketing authorization holder； National conditions；Cross-border holding and production；Divided manufacturing