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关于公开征求《硫唑嘌呤片生物等效性研究指导原则(征求意见稿)》等六项技术指导原则意见的通知-2023/8/22
2023-08-23查看详情 > -
国家药监局药审中心关于发布《罕见病酶替代疗法药物非临床研究指导原则(试行)》的通告(2024年第17号)-2024/2/23
2024-03-12查看详情 > -
Institutional Review Board (IRB) Written Procedures-2025/2/5
2025-02-06查看详情 > -
Document: Superseded opinion of the HMPC on Urtica dioica L., Urtica urens L. their hybrids or their mixtures, radix - First version-2025/3/12
2025-03-13查看详情 > -
Page: Eligible patients and consumers organisations-2025/4/14
2025-04-15查看详情 > -
Document: CTIS newsflash - 27 May 2025-2025/5/27
2025-05-28查看详情 > -
Page: Oseltamivir product-specific bioequivalence guidance-2025/6/30
2025-07-01查看详情 > -
Document: Day 80 assessment report - Clinical template with guidance - Rev. 07.25 - Revamp-2025/8/1
2025-08-04查看详情 > -
Page: Guidance on the application of the revised variations framework-2025/9/22
2025-09-23查看详情 > -
Page: Pre-authorisation guidance-2025/10/28
2025-10-29查看详情 >