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Page: Type-IB variations: questions and answers-2025/11/26
2025-11-27查看详情 > -
Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 20 November 2025-2025/12/18
2025-12-19查看详情 > -
国家药监局药审中心关于发布《神经病理性疼痛治疗药物临床试验技术指导原则（试行）》的通告（2026年第9号）-2026/2/4
2026-02-05查看详情 > -
Document: Applications for new human medicines under evaluation: March 2026-2026/3/11
2026-03-12查看详情 > -
Page: Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline-2026/4/9
2026-04-10查看详情 > -
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)-2022/12/21
2022-12-21查看详情 > -
关于公开征求《细胞和基因治疗产品临床相关沟通交流技术指导原则（征求意见稿）》意见的通知-2023/7/25
2023-07-28查看详情 > -
Final Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry-2024/2/29
2024-03-11查看详情 > -
Document: Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance-2025/1/31
2025-02-05查看详情 > -
Document: European Shortages Monitoring Platform (ESMP) User guide for national competent authorities-2025/3/10
2025-03-11查看详情 >
