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国家药监局药审中心关于发布《艾滋病免疫功能重建不全治疗药物临床试验技术指导原则》的通告（2025年第52号）-2025/12/30
2025-12-31查看详情 > -
Document: Agenda - Combination products operational group, Medical devices (MD) stream, 12 February 2026-2026/2/6
2026-02-09查看详情 > -
关于公开征求《抗肿瘤药物基于后线研究数据开展前线适应症临床试验技术指导原则（征求意见稿）》意见的通知-2026/3/17
2026-03-18查看详情 > -
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators-2026/4/20
2026-04-21查看详情 > -
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms(Draft)-2023/01/31
2023-01-31查看详情 > -
国家药监局关于修订榄香烯注射剂说明书的公告（2023年第109号）-2023/8/25
2023-08-28查看详情 > -
Final Guidance: Q14 Analytical Procedure Development-2024/3/6
2024-03-12查看详情 > -
药审中心发布《生物类似药说明书撰写技术指导原则》-2025/2/7
2025-02-10查看详情 > -
Document: Summary of the Medicine Shortages SPOC Working Party meeting on 21 January 2025-2025/3/12
2025-03-13查看详情 > -
Document: Minimum inhibitory concentration (MIC) breakpoints-2025/4/14
2025-04-15查看详情 >
