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Document: Overview of comments on ICH M4Q(R2) : Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality - Step 2b-2026/2/20
2026-02-27查看详情 > -
Document: Clinical Trial Information System (CTIS) - Sponsor Frequently Asked Questions (FAQ)-2026/3/26
2026-03-27查看详情 > -
Document: Minutes of the COMP meeting 17-18 March 2026-2026/5/5
2026-05-06查看详情 > -
Regulatory and procedural guideline: Member states contact points for translations review-2022/10/6
2022-11-15查看详情 > -
国家药监局关于修订金乌骨通胶囊药品说明书的公告（2023年第47号）-2023/4/24
2023-04-25查看详情 > -
国家药监局综合司关于印发药品上市许可持有人委托生产现场检查指南的通知-2023/10/24
2023-11-06查看详情 > -
国家药监局综合司关于《采用脑机接口技术的医疗器械 用于人工智能算法的脑电数据集质量要求与评价方法》推荐性医疗器械行业标准立项的公示-2025/1/13
2025-01-14查看详情 > -
Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC-2025/2/17
2025-02-18查看详情 > -
Document: List of medicinal products under additional monitoring-2025/3/26
2025-03-27查看详情 > -
Document: List of centrally authorised products with safety-related changes to the product information-2025/4/30
2025-05-06查看详情 >
