Abstract: Objective To provide references for drug marketing authorization holder (MAH) of China to establish adverse drug reaction direct reporting system. Methods The related literatures were collected to summarize the current status of adverse drug reactions reporting, analyze the existing problems in depth, draw on the experience of foreign MAHs and put forward the corresponding countermeasures. Results & ConclusionThe monitoring and reporting of adverse drug reactions in China started relatively late, and the pilot work of MAH is also at the stage of accumulating experience. Few reports were actively collected and the main responsibility needs to be improved. In this regard, it is necessary for China to learn from the more mature experience of the European Union, the United States and other countries, and to raise the level of pharmacovigilance by strengthening the awareness of MAH's main responsibility, building professional gathering teams, and broadening the channels for information collection.

Key words: marketing authorization holder(MAH), post-marketing, adverse drug reactions, current status