Asian Journal Of Social Pharmacy

Abstract: Objective To study the obligations and responsibilities that market authorization holders in China should bear, identify the problems that exist under the current system where MAH is the subject of obligation responsibility, and to put forward some solutions. Methods Literature review was used to analyze the regulatory documents related to the market authorization holder system issued by the government in the past five years to conclude the obligations and responsibilities that should be taken by MAHs. Besides, the obligations and responsible parties before and after the implementation of the MAH system were compared to identify the advantages of MAH as the first responsible person. Results and Conclusion It is critical for China to implement the MAH system in the field of drug regulation, but there are still many problems when MAHs assume obligations and responsibilities. Therefore, MAHs should improve their management capabilities, legal awareness and actively buying commercial insurance to respond to risks.

Key words: marketing authorization holder (MAH), obligation, responsibility