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关于公开征求《局部起效化学仿制药物理化学及结构（Q3）特性研究技术指导原则（征求意见稿）》意见的通知-2026/1/23
2026-01-26查看详情 > -
Page: Orphan designation: Overview-2026/2/27
2026-02-28查看详情 > -
Page: Risk management plans (RMP) in post-authorisation phase: questions and answers-2026/3/27
2026-03-30查看详情 > -
国家药监局关于发布仿制药参比制剂目录（第一百零五批）的通告（2026年第17号）-2026/5/11
2026-05-12查看详情 > -
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials-2026/6/24
2026-06-24查看详情 > -
国家药监局药审中心关于发布《氯雷他定片生物等效性研究技术指导原则》的通告（2022年第43号）-2022/11/25
2022-11-25查看详情 > -
Scientific guideline: Concept paper on the development of an addendum to the Guideline on clinical development of vaccines on clinical trials for vaccines for immunocompromised individuals-2023/11/3
2023-11-07查看详情 > -
国家药监局药审中心关于发布《放射性治疗药物申报上市临床风险管理计划技术指导原则》的通告（2025年第5号）-2025/1/16
2025-01-16查看详情 > -
Page: Data Analysis and Real World Interrogation Network (DARWIN EU)-2025/2/20
2025-02-21查看详情 > -
Document: Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 1 April 2025-2025/3/28
2025-04-01查看详情 >
