药品事中事后监管机制研究

Research on the Mechanism of Drug Interim and Ex Post Supervision

药品事中事后监管机制的创建,是推进《药品管理法》《疫苗管理法》有效实施、药品安全“十四五”规划编制的关键性条件。基于当前药品事中事后监管的制度安排和监管技术制度现状的分析,本文归纳了药品事中事后监管的市场主体、质量体系、产品3方面内容,分析许可与监管、技术与行政两种分离方式等特征,提出需要加快药品监管方式向事中事后转变,强化和规范药品事中事后监管的政府协调机制、信用监管、大数据决策、合规性建设等政策性建议;提出以强化药品全过程和风险管理为重点,以推进监管科学发展为抓手,抓改革、保安全、提质量、强基础,完善监管体制机制,创新监管方式方法,深化企业主体责任落实,提高药品监管的科学化、法制化、国际化、现代化水平,为推进“两法两条例”宣贯工作和“十四五”国家药品安全规划编制提供行之有效的决策参考。

The establishment of drug interim and ex post supervision mechanism is a key condition for the implementation of Drug Administration Law,Vaccine Administration Law,and the preparation of 14th Five-Year Plan of Drug Safety.Based on analyzing of the current system arrangements and regulatory technology status for the drug supervision mechanism,the author summarized the three aspects of the market subject,quality system and product about drug interim an ex post superision.The author analyzed the characteristics of the separation methods of licensing and supervision,technology and administration,and proposed that it is necessary to accelerate the trans formation of drug supervision methods to interim and ex post supervision.At last the author proposed to strengthen and standardized the drug interim and ex post supervision from the government coordination mechanism,credit supervision,big data decision-making,compliance system,and so on.Strengthening the drug entire process and risk management,and focusing on the administrtation science development,which would improved the reforming,safety,quality,and foundation of drug supervision.The drug administration bureau need to continuously improve the regulatory mechanism,innovate regulatory methods,and deepen the implementation of enterprise responsibility.Improveing the scientific,legal,international,and modern level of drug supervision,which would provided an effective decision-making reference for the promotion of the Two Laws and Two Regulations and the formulation of National Drug Safety 14th Five-Year Plan.