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Document: European Shortages Monitoring Platform (ESMP) User guide for national competent authorities-2025/5/13
2025-05-14查看详情 > -
国家药监局药审中心关于发布《局部起效化学仿制药体外释放（IVRT）与体外透皮（IVPT）研究技术指导原则（试行）》的通告（2025年第22号）-2025/6/20
2025-06-23查看详情 > -
Page: CHMP opinions on consultation procedures-2025/7/24
2025-07-25查看详情 > -
Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions - track changes-2025/9/10
2025-09-11查看详情 > -
Document: Agenda - PDCO agenda of the 14-17 October 2025 meeting-2025/10/14
2025-10-15查看详情 > -
Document: Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)-2025/11/18
2025-11-19查看详情 > -
Document: CTIS Simplification Task Force: topics for analysis-2025/12/12
2025-12-15查看详情 > -
Document: Agenda - PDCO agenda of the 27-30 January 2026 meeting-2026/1/27
2026-01-28查看详情 > -
国家药监局药审中心关于发布《抗肿瘤药物生物等效性及药代动力学比对研究受试者人群选择考虑》的通告（2026年第22号）-2026/3/5
2026-03-06查看详情 > -
国家药监局关于“人工智能+药品监管”的实施意见-2026/4/2
2026-04-03查看详情 >
