我国生物制品的病毒安全性管理现状及检验检疫监管的探讨

The viral safety management status of biological products and discussion on the inspection and quarantine supervision

目的分析检验检疫部门对出入境生物制品病毒安全性管理需要关注的几个方面。方法通过分析生物制品病毒安全性控制的迫切性和我国生物产品的病毒安全性管理现状,探讨检验检疫部门对出入境生物制品病毒安全性管理需要关注的重点。结果需完善生物技术产品病毒安全性相关法规文件和技术指导原则和病毒安全性技术检测体系。结论检验检疫部门需加强出入境生物制品的病毒安全性检测能力、加强合作,提升检验检疫部门出入境生物制品病毒安全性监测能力。

Objective Analyzing the viral safety management of biological products of entry-exit inspection and quarantine department need attention. Methods Through analyzing the urgency of virus safety control and management situation of biological products, we discuss the focus of concern viral safety management of entry-exit biological products concern. Results We need to improve viral safety related regulatory documents and technical guidelines of biotechnology products and viral safety technology inspection system immediately. Conclusion Entry-exit inspection and quarantine department requires developing of entry and exit biologics viral safety testing capability, strengthen cooperation, enhancing the entry-exit inspection and quarantine departments biologics viral safety monitoring capabilities.