福建省药品审评与监测评价中心赴宁德调研药品生产企业
来源:福建省药品审评与监测评价中心 时间:2023-08-01 17:58

近日,为进一步了解和帮扶持有人开展药品上市后变更和药物警戒工作,省药品审评与监测评价中心李宗主任带队到福建古田药业有限公司开展调研工作。

调研组与企业代表开展座谈交流,了解持有人不良反应报告自主上报情况和新厂区新增生产线及异地整体搬迁过程中遇到的产品注册变更有关问题。

 

调研组肯定了古田药业近几年的药物警戒工作,强调持有人要落实好药物警戒主体责任,根据法规进一步做好药品不良反应自主报告收集、评价及上报工作,还回答了企业关注的注册变更遇到的技术问题。             

 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              

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