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Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)-2025/11/7
2025-11-10查看详情 > -
Document: Product Management Service (PMS) roadmap-2025/12/8
2025-12-09查看详情 > -
Page: European Shortages Monitoring Platform (ESMP)-2026/1/16
2026-01-19查看详情 > -
Document: Agenda - Medicine Shortages SPOC Working Party meeting 17 February 2026-2026/2/17
2026-02-27查看详情 > -
Page: Changing the (invented) name of a centrally authorised medicine: questions and answers-2026/3/25
2026-03-26查看详情 > -
Page: Liraglutide 6 mg/mL solution for injection in a prefilled pen product-specific bioequivalence guidance-2026/4/30
2026-05-02查看详情 > -
Document: Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda-2026/6/12
2026-06-15查看详情 > -
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (Final)-2022/10/13
2022-11-15查看详情 > -
国家药监局药审中心关于发布《基因治疗血友病临床试验设计技术指导原则》的通告（2023年第29号）-2023/4/14
2023-04-14查看详情 > -
国家药监局药审中心关于发布《药物临床试验方案提交与审评工作规范》的通告（2023年第51号）-2023/10/13
2023-10-13查看详情 >
