药品上市许可持有人制度对药品监管工作的影响和思考

Influence and Reflection of Marketing Authorization Holder System on Drug Regulation

目的:开展前瞻性研究,探索药品上市许可持有人风险管控措施。方法:通过对北京市药品上市许可持有人制度试行工作进展情况进行调研,分析新政落地给药品监管工作带来的影响,并结合实际探讨监管策略。结果与结论:药品上市许可持有人正处于萌芽期。持有人监管面临的挑战主要来自于监管依据不足、监管任务增加、监管难度提升以及监管人员素质要求高等问题。建议采取建立健全检查依据、转变观念创新监管、推进职业化检查员队伍建设、营造良好的持有人生存环境以及践行科学研究精神等措施加强持有人监管。

Objective:To carry out prospective study and explore risk management and control measures for Marketing Authorization Holder.Methods:The influence of the Marketing Authorization Holder system on drug regulation was analyzed by investigating the progress of the trial implementation of the system in Beijing.Moreover,the supervision strategy for the system was analyzed based on practice.Results and Conclusion:The Marketing Authorization Holder is still in its infancy.The challenges of regulation of the system come from insufficient regulatory basis,increased regulatory tasks,increased regulatory difficulty and the high quality requirements of supervisors.It is suggested that measures should be taken to strengthen the supervision of the holders,such as establishing and improving the inspection basis,changing the concept and innovating the supervision,promoting the construction of professional inspectors,creating a good living environment for the holders,as well as carrying out spirit of scientific research.