A Questionnaire Survey and Result Analysis on the Implementation Pathway of the Marketing Authorization Holder(MAH)System in China
Objective:To investigate key issues and management elements of implementing the marketing authorization holder(MAH)system in China and to support related solutions and proposals.Methods:The study combines an analysis of the major issues in implementing relevant laws and regulations of the MAH system in China and in-depth investigation of MAH regulatory systems in Europe,the United States,Japan,and other countries and regions.Key issues in regulations,regulatory systems,and liability compensation are extracted,and a questionnaire survey is designed among pharmaceutical professionals.Results and Conclusion:The results of the survey reflect a consensus among most respondents on key issues and solutions for implementing the MAH system in the entire life cycle of drugs in China.Survey results also show that some key issues still need to be further explored.
万方数据
维普
