《化学药品注射剂仿制药质量和疗效一致性评价技术要求》等3个文件的通告(2020年第2号 ...

2023-4-7 12:30| 发布者: 国正行| 查看: 471| 评论: 0|来自: 国家药监局药审中心

摘要: 申请人应全面了解已上市注射剂的国内外上市背景、安全性和有效性数据、上市后不良反应监测情况,评价和确认其临床价值;应按国家药监局发布的《化学仿制药参比制剂遴选与确定程序》科学选择参比制剂,参照本技术要求 ...


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