Abstract: Objective To provide reference for improving adverse drug reactions(ADR) reporting capabilities of drug manufacturers by investigating the medical institutions' attitude towards establishing a direct reporting system based on drug manufacturers and the current status of information collection on ADR by drug manufacturers from medical institutions. Methods Six representative provinces/municipalities were selected nationwide, and one medical institution of each was selected from each of the three grades. Questionnaires and interviews on the collection of ADR information by enterprises were conducted with the medical staff, and the results were counted and analyzed. Results Medical institutions suffered mixed fortunes in the implementation of the direct reporting system, and enterprises would face many challenges. At present, the collection of ADR information by enterprises from medical institutions was not smooth, and the status was not optimistic. Conclusion In order to improve the ADR reporting capacity of drug manufacturers, it is necessary for medical institutions, enterprises and government departments to simultaneously exert efforts to jointly promote the smooth implementation of the direct reporting system.

Key words: drug manufacturers, direct reporting system, medical institutions, current status investigation