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国家药监局药审中心关于发布《发酵或半合成化学仿制药抗生素有关物质限度制定指导原则》的通告（2025年第28号）-2025/7/30
2025-07-31查看详情 > -
国家药监局综合司关于印发医疗器械注册自检核查指南的通知-2025/9/16
2025-09-17查看详情 > -
2025年10月21日中药品种保护受理公示-2025/10/21
2025-10-22查看详情 > -
Document: PRAC recommendations on signals adopted at the 27-30 October 2025 PRAC meeting-2025/11/24
2025-11-25查看详情 > -
Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP)-2025/12/16
2025-12-17查看详情 > -
Document: Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development-2026/1/30
2026-02-02查看详情 > -
Document: SMS guidance for external users-2026/3/10
2026-03-11查看详情 > -
Document: Veterinary medicine safety day: Why read veterinary medicines package leaflet-2026/4/8
2026-04-09查看详情 > -
Document: Questions and answers on periodic safety update report single-assessment (PSUSA): Guidance document for assessors-2026/5/22
2026-05-25查看详情 > -
国家药监局药审中心关于发布《药物临床试验盲法指导原则（试行）》的通告（2022年第49号）-2022/12/30
2022-12-30查看详情 >
