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Document: Minutes - HMA-EMA joint Network Data Steering Group meeting - 11 February 2026-2026/3/13
2026-03-16查看详情 > -
Document: PDCO minutes of the 24-27 February 2026 meeting-2026/4/13
2026-04-14查看详情 > -
关于公开征求《儿童药物临床试验中应用患者报告结局(PRO)技术指导原则(征求意见稿)》意见的通知-2026/5/29
2026-05-31查看详情 > -
Regulatory and procedural guideline: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 7 (updated)-2023/01/18
2023-01-18查看详情 > -
Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008(update)-2023/7/31
2023-08-02查看详情 > -
2023年度药品审评报告-2024/2/4
2024-03-12查看详情 > -
Document: Committee for Advanced Therapies (CAT): Work Plan 2025-2025/2/3
2025-02-05查看详情 > -
Document: List of medicines currently in PRIME scheme-2025/3/11
2025-03-12查看详情 > -
Page: Assessment templates and guidance-2025/4/11
2025-04-13查看详情 > -
Document: Test cases (1a-10) RTFs-2025/5/23
2025-05-26查看详情 >