我国非生产企业成为上市许可持有人的可能性与挑战

Possibility and Challenge of Non-production Enterprises in Our Country to Become a Marketing Authorization Holder

目的基于《药品管理法》修订和《上市许可持有人制度试点方案》,探讨非生产企业成为上市许可持有人的可能性以及实施路径。方法通过统计2014年8月到2015年8月CFDA受理的1.1类化学药品,分析药品上市申请人中非生产企业的性质、注册时间和注册资金等基本情况,同时以《上市许可持有人制度试点方案》中权利义务规定为基础,研究非生产企业成为上市许可持有人的可能性及挑战。结果近一年内CFDA受理的1.1类化学药品中非生产企业占较大比重,药品安全有效性相关责任将是其成为上市许可持有人的门槛。结论非生产企业应在完善质量管理和药品监测部门的前提下申请成为持有人,同时为使试点方案顺利实施,我国还需对上市许可持有人制度进行完善并建立药害赔偿救济基金等配套政策。

Objective To explore the possibility of non-production enterprises to become the marketing authorization holder and its implementation path based on revision of the Drug Administration Law and marketing authorization holder（MAH） pilot program. Methods Through statistics of 1.1 class chemicals accepted by China Food and Drug Administration（CFDA） during August 2014 to August 2015, the basic situation of non-production enterprises listed applicants were analyzed, such as their nature, registration time and capital. As well, based on the rights and obligations stipulated in the MAH pilot program, the possibility of non-production enterprises to become the MAHs was analyzed. Results The non-production enterprises have accounted a large proportion in 1.1 class chemicals accepted by CFDA in nearly one year, the responsibility of drug safety and effectiveness will become a threshold for these enterprises to be MAHs. Conclusion To become MAHs, non-production enterprises should improve the quality management and monitoring departments. At the same time, our country still needs to improve MAH system, such as establishing the adverse drug event relief fund for compensation and other supporting policies to promise of smooth implementation for MAH pilot program.