OBJECTIVE： To explore the cognition， willingness and implementation obstacles of pharmaceutical manufacturers to Marketing authorization holder （MAH） system in Shanghai， and to provide the suggestions for further perfecting the system. METHODS： Questionnaire survey was conducted among pharmaceutical manufacturers in China. The cognition， willingness and obstacles of pharmaceutical manufacturers to implementing MAH system were collected and summarized to put forward the suggestions. RESULTS： A total of 193 questionnaires were sent out （one cope for each manufacturer）； 180 valid questionnaires were collected with effective rate of 93.3％. Average score about the cognition of Shanghai pharmaceutical manufacturers to implement system was 40.8％； the overall positive rate for the system was 92.2％. 89.4％ of manufacturers were willing to become holders， and 85.0％ were willing to accept entrusted production. Manufacturing enterprises with low utilization rate of equipment and without special pharmaceutical R&D department had strong desire to implement MAH system. Enterprises believed that the major obstacles were the imperfect insurance mechanism （173 manufacturers， 96.1％） and the difficulty in monitoring the offsite （162 manufacturers， 90.0％）. CONCLUSIONS： There is a deviation in the cognition of Shanghai pharmaceutical manufacturers to MHA system， however manufacturers have strong will to become holders and accept entrusted production. For reasons that manufacturers are reluctant to implement， the drug regulatory department should strictly monitor all key points， timely and effectively communicate and cooperate to form a regulatory joint force and thus ensure the smooth progress of MAH system.