基于标准化模型构建药品质量风险管控体系的研究

Study on the Risk Management System of Drug Quality Based on the Standardized Model

目的探索构建一套切实可操作的制度化、数据化药品质量风险管控标准化模型及运行体系。方法从风险评估、风险控制、风险交流、风险审核等方面阐述药品质量风险管控的应用研究。结果宁波市药品监管部门将药品质量风险信息标准化、风险评估指标体系实践应用于药品生产、流通、不良反应监测、药品检验、社会共治等环节。结论药品质量风险管控体系化建设不断完善,并提出实施药品质量风险管控标准化体系建设工作的建议,为当前的药品监管提供科学的创新思路。

OBJECTIVE To explore constructing the practical risk management system of drug quality based on the standardized model. METHODS The application and research of risk assessment, risk control, risk communication and risk review in Ningbo were described. RESULTS The application of the standardized drug quality risk information and risk assessment index system had been made by the Ningbo drug regulatory departments in the drug production, circulation, adverse reactions monitoring, drug control and social cohabitation. CONCLUSION The risk management system of drug quality hasbeen constantly improved. And suggestions are put forward to innovate ideas for drug supervision and administration.