新版《药品质量抽查检验管理办法》简介及实施建议

Introduction and implementation suggestions of revised Regulations on Drug Quality Sampling and Testing

2019年8月,国家药品监督管理局颁布了《药品质量抽查检验管理办法》,同时废止了2006年7月颁布的《药品质量抽查检验管理规定》,对中国药品上市后质量抽查检验和质量评价提出了新要求。《药品质量抽查检验管理办法》针对当前及未来的监管形势,新增或修订了组织管理、抽检计划、样品抽取、检验复验、监督管理、信息公开各环节的诸多内容,对打击假劣药品和挖掘潜在质量安全风险具有重要意义,建议相关工作人员予以重视并落实到位。

In August 2019,the National Medical Products Administration issued the"Regulations on Drug Quality Sampling and Testing",and abolished the version issued in July 2006,making new requirements for post-market quality sampling and testing and quality evaluation of drugs in China.In view of the current and future regulatory situation,this version has added or revised many contents of organizational management,planning,sampling,testing and re-testing,supervision,and information disclosure,etc,which is of great value in combating counterfeit and substandard drugs and preventing and controlling potential quality and safety risks,and it is recommended that relevant staff members pay attention and implement it in place.