Abstract: This paper reviewed the progress in the implementation of the system of direct reporting of adverse reactions by drug marketing authorization holders(MAHs), and analyzed the challenges facing MAHs, including the low report rate of ADRs from enterprises, communication barriers encountered by MAHs, pressure and concerns of medical institutions, and duplicate reporting. This study gave some tips on how to learn from foreign countries, address concerns over reporting on the part of all reporting parties, actively strengthen the reporting obligations of MAHs, open reporting channels and prevent duplicate reporting from the perspective of system implementation and practice.

Key words: marketing authorization holders(MAHs), direct reporting, adverse reaction, adverse event