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Page: Paediatric investigation plans: questions and answers-2026/4/14
2026-04-15查看详情 > -
Procedural advice for vaccine platform technology master file (vPTMF) certification - Scientific guideline (updated)-2023/01/27
2023-01-27查看详情 > -
国家药监局药审中心关于发布《放射性化学仿制药药学研究技术指导原则》的通告(2024年第11号)-2024/2/5
2024-03-12查看详情 > -
Page: Biosimilar Medicinal Products Working Party-2025/2/4
2025-02-05查看详情 > -
国家药监局综合司公开征求《二代基因测序相关体外诊断试剂分类界定指导原则(征求意见稿)》意见-2025/3/12
2025-03-13查看详情 > -
Page: Medical devices-2025/4/11
2025-04-13查看详情 > -
国家药监局综合司关于贯彻实施《医疗器械网络销售质量管理规范》有关事项的通知-2025/5/26
2025-05-27查看详情 > -
Page: Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects-2025/6/30
2025-07-01查看详情 > -
国家药监局关于发布《医疗器械生产许可与备案管理基本数据集》等2个信息化标准的公告 (2025年第75号)-2025/8/1
2025-08-04查看详情 > -
Page: The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus - Scientific guideline-2025/9/19
2025-09-22查看详情 >