Abstract: Objective： This research will have a brief introduction on the pharmacovigilance responsibility of Marketing Authorization Holder（MAH）in EU and then provide references for the establishment and improvement of MAH′s direct reporting of adverse drug reactions in China. Methods：Through consulting domestic literature, EU official website, EU drug alert system to analyze the EU drug pharmacovigilance system and the pharmacovigilance responsibility of MAH. Results： EU has some very detailed regulations on the pharmacovigilance responsibilities of MAH， including the responsibility of reporting the adverse drug reaction， the responsibility of managing qualified pharmacovigilance personnel， the responsibility of implementing the quality system， and the responsibility of managing the subcontracted pharmacovigilance quality system. Conclusion： It is necessary that we should take further actions to establish and improve the system that allows the MAH in our country to report the ADR directly， and then hopefully these cations will improve the ability to monitor the ADR in our country