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Electronic Submission Template for Medical Device Q-Submissions Draft Guidance for Industry and Food and Drug Administration Staff-2025/5/29
2025-06-06查看详情 > -
Page: Medical device expert panels-2025/7/10
2025-07-11查看详情 > -
Approaches to Assessment of Overall Survival in Oncology Clinical Trials-2025/8/19
2025-08-20查看详情 > -
Document: Minutes of the HMPC meeting 7-9 July 2025-2025/9/29
2025-09-30查看详情 > -
Page: Safety of medicines-2025/11/6
2025-11-07查看详情 > -
国家药监局药审中心关于发布《疫苗临床试验不良事件分级标准指导原则(修订版)》的通告(2025年第49号)-2025/12/5
2025-12-08查看详情 > -
国家药监局关于化学药品和生物制品全面实施药品电子通用技术文档申报的公告(2026年第8号)-2026/1/15
2026-01-16查看详情 > -
Page: Good pharmacovigilance practices (GVP)-2026/2/16
2026-02-26查看详情 > -
Document: Minutes – Ad hoc Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - 5 March 2026-2026/3/24
2026-03-25查看详情 > -
Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026-2026/4/29
2026-04-30查看详情 >