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国家药监局综合司关于2025年医疗器械行业标准制修订计划项目公示-2025/2/24
2025-02-25查看详情 > -
Document: Call for scientific data for the periodic review of the monograph on Harpagophyti radix-2025/4/1
2025-04-02查看详情 > -
Page: Opinions and letters of support on the qualification of novel methodologies for medicine development-2025/5/8
2025-05-09查看详情 > -
关于公开征求《创新药临床试验申请申报资料要求》等相关文件(征求意见稿)意见的通知-2025/6/19
2025-06-20查看详情 > -
Document: Marketing authorisation application (MAA) - pre-submission interactions form-2025/7/23
2025-07-24查看详情 > -
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes-2025/9/8
2025-09-09查看详情 > -
Document: ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5-2025/10/10
2025-10-11查看详情 > -
Page: Scientific advice and protocol assistance-2025/11/17
2025-11-18查看详情 > -
Page: Stability testing for applications for variations to marketing authorisation - Scientific guideline-2025/12/12
2025-12-15查看详情 > -
国家药监局关于暂停进口、销售和使用Supriya Lifescience Ltd.马来酸氯苯那敏原料药的公告(2026年第14号) -2026/1/26
2026-01-27查看详情 >