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中药新药用于慢性胃炎的临床疗效评价技术指导原则(试行)-2022/12/21
2022-12-22查看详情 > -
关于公开征求《抗肿瘤药物说明书安全性信息撰写技术指导原则(征求意见稿)》意见的通知-2023/6/30
2023-06-30查看详情 > -
Development and manufacture of human medicinal products specifically designed for phage therapy - Scientific guideline-2023/12/22
2024-01-03查看详情 > -
Document: Product Management Service (PMS) roadmap-2025/1/24
2025-02-05查看详情 > -
Document: Minutes of the CAT meeting 22-24 January 2025-2025/2/27
2025-03-03查看详情 > -
国家药监局关于进一步做好《药品生产许可证》发放有关事项的公告政策解读-2025/4/7
2025-04-08查看详情 > -
Document: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.5-2025/5/15
2025-05-16查看详情 > -
国家药监局关于发布YY 0300—2025《牙科学 修复用人工牙》等38项医疗器械行业标准的公告(2025年第59号)-2025/6/25
2025-06-26查看详情 > -
Document: Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop-2025/7/28
2025-07-29查看详情 > -
国家药监局关于发布仿制药参比制剂目录(第九十六批)的通告(2025年第34号) -2025/9/12
2025-09-12查看详情 >