关于完善我国正电子放射性药品监督管理的建议

Suggestions on the Improvement of Supervision and Management of Positron Emission Tomography Drugs in China

目的:为完善我国正电子放射性(PET)药品监督管理提供参考。方法:就我国PET药品的发展、管理的现状和PET药品的研发、注册、生产及流通中存在的问题进行探讨。结果与结论:基于临床诊疗实践的迫切需求,PET药品在我国的应用日益广泛,但存在研发力量薄弱、基础研究滞后、注册管理过于苛刻、生产管理欠规范等问题。建议我国应加强PET药品注册、生产和流通管理,推进针对PET药品的生产质量管理规范的制订,加大对PET药品研发的支持力度,促进PET药品的合理应用。

OBJECTIVE：To provide references for improving supervision and management of positron emission tomography （PET）drugs in China.METHODS：The development and management situation of PET drugs were presented,and the problems existing in research,registration,production and circulation of PET drugs were also interpreted.RESULTS CONCLUSIONS：Based on the urgent needs of clinical diagnosis and treatment,PET drugs are becoming widespread increasingly;there still are some problems,such as weak RD capability,lagging of basic study,excessively strict registration and management,non-standardized production and management,etc.It is suggested that the government should strengthen the management of PET drugs in the process of registration,production and circulation,propel to formulate good manufacturing practice for PET drugs,give more supports to RD of PET drugs,and promote rational use of PET drugs.