我国实施预防用生物制品上市许可持有人制度的挑战及建议  

Challenges and suggestions for implementing marketing authorization holder system for preventive biological products in China

作　　者：王雪薇 戴伟 冯霄婵 石男 杨悦[2,3] WANG Xue-wei;DAI Wei;FENG Xiao-chan;SHI Nan;YANG Yue(China National Biotech Group Company Limited,Beijing 100029,China;Business Administration School,Shenyang Pharmaceutical University,Shenyang 110016,China;International Food &Drug Policy and Law Research Center,Shenyang 110016,China)

机构地区：[1]中国生物技术股份有限公司,北京100029 [2]沈阳药科大学工商管理学院,沈阳110016 [3]沈阳药科大学国际食品药品政策与法律研究中心,沈阳110016

出　　处：《中国新药杂志》2018年第23期2765-2769,共5页Chinese Journal of New Drugs

摘　　要：近年来预防用生物制品的重要性愈发凸显,从国际经验看,国外的上市许可持有人制度并未对适用药品类别进行限制。本文基于《药品上市许可持有人制度试点方案》,分析我国预防用生物制品的管理现状。参考WHO国家疫苗监管体系评估的上市许可部分要求,分析美国上市许可持有人制度。建议我国可在预防用生物制品中实施上市许可持有人制度。但鉴于预防用生物制品的特殊性,具有较高风险,因此应对预防用生物制品给予特殊的上市许可持有人制度设计。建议我国在进行预防用生物制品上市许可持有人制度设计的过程中,明确申请人资格,对持有人变更采取风险控制措施,开展预防用生物制品场地登记制度,在特殊情况下有条件放开委托生产限制并按照场地变更进行管理。In recent years,the importance of preventive biological products has become more prominent. Following the international experience,the foreign marketing authorization holder (MAH)system does not restrict the applicable drug categories.Basing on the pilot program of drug MAH system,we analyzed the management of preventive biological products in China.According to the marketing authorization requirements of WHO Vaccine National Regulatory Authority assessment tools,we analyzed the MAH system in USA.It is suggested that we could implement preventive biological products MAH system in China.However,the preventive biological products have unique characteristics,they are at high risk to be implemented the system.We should be provided a special- designed MAH system for preventive biological products.It's suggested that during the process of designed MAH system in China,applicant qualification should be defined,risk control measures for holder changes should be taken,the registration system of preventive biological products should be implemented,commissioned production restritions should be conditional released,and management should be performed according to site change in particular cases.

关 键 词：预防用生物制品 上市许可持有人 WHO国家疫苗监管体系 委托生产 

分 类 号：R95[医药卫生—药学]