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国家药监局关于发布中药生产监督管理专门规定的公告（2025年第79号）-2025/9/8
2025-09-09查看详情 > -
Document: Annual report of the Pharmacovigilance Inspectors Working Group for 2024-2025/10/9
2025-10-10查看详情 > -
Page: Task Forces-2025/11/17
2025-11-18查看详情 > -
国家药监局关于修订更年安制剂、复方当归注射剂药品说明书的公告（2025年第115号）-2025/12/12
2025-12-15查看详情 > -
Document: Joint controllership arrangement with regard to EudraVigilance Human (EV)-2026/1/23
2026-01-26查看详情 > -
Document: Questions and answers on the use of out-of-specification batches of authorised cell and tissue-based advanced therapy medicinal products-2026/3/3
2026-03-04查看详情 > -
Document: Draft Qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies-2026/3/31
2026-04-01查看详情 > -
Document: Timetable: Initial (Full) marketing authorisation application - ATMP-2026/5/13
2026-05-14查看详情 > -
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure-2022/11/4
2022-11-30查看详情 > -
ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline-2023/5/24
2023-05-25查看详情 >
