朱娟 王晓曦 张景辰

    摘 要 通过分析上海市药品再注册工作的申报概况和存在的主要问题，结合新版《药品注册管理办法》，对新形势下的药品再注册工作进行思考并提出建议，希望能充分发挥药品再注册在上市后药品监管中的作用，提高对上市后药品的风险控制和监管能力，确保申请人履行主体责任，更好地保障公众用药的安全、有效和质量可控。

    关键词 药品再注册 上市后药品 风险控制 监管建议

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2021)13-0003-03

    Thoughts and suggestions on drug re-registration under the new situation

    ZHU Juan， WANG Xiaoxi， ZHANG Jingchen

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT This paper analyzes the general situation of drug re-registration and the main problems in the re-registration work and propose some thoughts and suggestions on drug re-registration work under the new situation in combination with the newly promulgated Measures for the Administration of Drug Registration. It is hoped to give full play to the role of drug reregistration in post-marketing drug supervision， to improve the risk control and supervision ability of post-marketing drugs， to ensure the applicants to fulfill their main responsibility and better guarantee the safety， effectiveness and quality controllability of public medication. ......