上海市药品生产企业对上市许可持有人制度认知、意愿以及其实施中面临障碍的调查研究

Investigation and Study on the Cognition,Willingness and Implementation Obstacles of Shanghai Pharmaceutical Manufacturers to Marketing Authorization Holder System

目的:探索上海市药品生产企业对上市许可持有人(MAH)制度的认知、意愿以及其实施中面临的障碍,为进一步完善该制度提供建议。方法:通过向上海市药品生产企业发放调查问卷,收集企业对MAH制度的认知情况、执行意愿以及实施过程中所面临的障碍,进行总结并提出建议。结果:共发放问卷193份(每个企业1份),回收有效问卷180份,有效率为93.3%。上海市药品生产企业对MAH制度认知得分率为40.8%,对制度整体好评率为92.2%;有89.4%的企业愿意成为MAH,85.0%的企业愿意接受委托生产。设备利用率低、无专门药品研发部门的生产企业实施MAH制度意愿强烈。企业认为MAH制度实施所面临的主要障碍为保险机制不完善(173家,占比96.1%)、异地监管难开展(162家,占比90.0%)。结论:上海市药品生产企业对MAH制度认知存在一定偏差,但企业成为MAH的意愿和接受委托生产的意愿较强。针对企业不愿执行该制度的原因,建议药物监督与管理部门针对各个关键环节进行严格监管,各地药监部门间需进行及时有效地沟通和合作,形成监管合力,进而保证MAH制度的顺利推进。

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.