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Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)-2023/7/31
2023-08-02查看详情 > -
国家药监局关于印发优化药品补充申请审评审批程序改革试点工作方案的通知 国药监药注〔2024〕10号-2024/2/7
2024-03-12查看详情 > -
Document: Nanotechnology-based medicinal products for human use EU-IN Horizon Scanning Report-2025/2/3
2025-02-05查看详情 > -
Page: PRIME: priority medicines-2025/3/11
2025-03-12查看详情 > -
Page: Clinical investigation of medicinal products in the treatment of depression - Scientific guideline-2025/4/11
2025-04-13查看详情 > -
Document: European Union example instances - E2B(R3) testing files-2025/5/23
2025-05-26查看详情 > -
Page: Apixaban product-specific bioequivalence guidance-2025/6/30
2025-07-01查看详情 > -
Document: IRIS guide to registration and RPIs-2025/7/31
2025-08-01查看详情 > -
图解海报 | 《中药生产监督管理专门规定》发布（六）-2025/9/21
2025-09-22查看详情 > -
Document: List of signals discussed at PRAC since September 2012-2025/10/27
2025-10-28查看详情 >
