新的特殊药品监管政策下放射性药品检验工作探讨

Discussion on the inspection of radiopharmaceuticals under the new special drug supervision policy

为落实放射性药品新的监管政策,适应产业和核医学新的发展趋势,本研究采用法规和文献梳理、专家访谈的方式,结合放射性药品检验工作实践,提出检验机构发展和监管与检验有效衔接的建议。建议省级药品检验机构尽快扩充放射性药品检验资质,满足属地监管需求,解决与产业发展不相匹配的问题;建议明确生产许可检验和医疗机构备案检验启动要求,进一步完善监管与检验衔接工作程序,更有效地发挥检验技术支撑作用。

In order to implement the new regulatory policy for radiopharmaceuticals and adapt to the new trend of industry and development of nuclear medicine, this research combining with the working experience of radiopharmaceutical inspection proposes, suggests on the development of inspection institutions and the effective connection between supervision and inspection using review of regulations and literature, expert interviews. It is recommended that the provincial drug inspection agencies should accelerate to expand the qualification of radiopharmaceutical inspection in order to meet the requirement of territorial supervision and solve the problems that do not match the current industrial development. It is also recommended to clarify the requirements for the initiation of production license inspection and medical institution filing inspection, further improve the working procedures for the connection between supervision and inspection, and effectively play the supporting role of inspection technology.