Suggestions on the Key Issues of the Implementation Pathway of the Marketing Authorization Holder(MAH)System in China
In view of the main issues in the relevant laws and regulations and implementation process of the marketing authorization holder(MAH)system in China,as well as the key issues in the implementation of MAH system in China extracted on the basis of in-depth research on the MAH regulatory systems in the European Union,the United States,Japan and other countries and regions,this article combines the results of the implementation path questionnaire survey,focus on the core principles of MAH implementation and under the current regulatory framework,and put forward suggestions for improving the implementation path of MAH system in China from two aspects:overall considerations and key issues for the implementation of the MAH system.