风险管理视角下的国家药品抽检沿革分析与现实挑战

Formation Analysis and Actual Challenges of National Drug Sampling and Testing Program from the Perspective of Risk Management

关键词:  风险管理  国家药品抽检沿革  政策工具

Key words:  risk management  formation of national drug sampling and testing program  policy instruments

摘要:

目的 基于风险管理理念，从法规制度变迁、管理机构变化、政策工具使用等方面梳理国家药品抽检沿革与现状，分析后疫情时代国家药品抽检面临的挑战与对策。方法 采用文献研究法，汇总国家药品抽检相关法规政策、既往档案、程序性文件与研究文献等信息，分析各阶段风险管理体系变化与政策工具使用情况。结果 国家药品抽检沿革可分为5个阶段，经过各阶段发展，抽检目的由防控假劣药品逐渐向促进行业高质量发展转变，制度框架逐步覆盖抽检全部流程，检验方式也逐步从单一标准检验变为利用探索性研究充分发现潜在风险。结论 国家药品抽检建立的质量风险管理体系与政策工具基本完成了各个时期的历史任务，但仍面临日趋复杂的供应链环境、相对独立的数据监管模式、如何以临床为导向监测使用环节质量风险等带来的现实挑战。

Abstract:

OBJECTIVE To review and summarize the formation and current situation of national drug sampling and testing program from transition of laws and regulations,institutional changes,utilization of policy instruments based on the concept of risk management,and analyze the actual challenges and possible strategies in the post-pandemic era.METHODS The literature research method was used to summarize the national laws,regulations and policies related to drug sampling inspection,past archives,procedural documents and research literature,and the changes in the risk management system and the use of policy tools at various stages was analyzed.RESULTS The formation of national drug sampling and testing program could be divided into five phases,by years of development,the goal of national drug sampling and testing program had been transferred from controlling counterfeit drugs to contributing the high-quality development of pharmaceutical industry.The legal framework was growing to cover the whole sampling and testing system.The way of testing also had became to find the potential quality risk by exploratory research,instead of merely testing the products by quality standards.CONCLUSION The quality risk management system built by the national drug sampling and testing program has complete the historic tasks in all phases.However,the system still faces to the challenges such as the growing complexity of drug supply chains,isolated data regulation mode and how to construct the mechanism of monitoring drug quality in clinical oriented model.