首页 >
法规速递
-
关于公开征求《治疗用生物制品批准后药学变更管理方案起草及评价技术指导原则（征求意见稿）》意见的通知-2025/9/11
2025-09-12查看详情 > -
Document: IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants-2025/10/14
2025-10-15查看详情 > -
Document: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2025-2025/11/19
2025-11-20查看详情 > -
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes-2025/12/15
2025-12-16查看详情 > -
国家药监局药审中心关于发布《用于术后镇痛的长效局部麻醉药临床试验技术指导原则（试行）》的通告（2026年第2号）-2026/1/28
2026-01-29查看详情 > -
Document: Darwin EU: Making health data count-2026/3/6
2026-03-09查看详情 > -
Document: List of signals discussed at PRAC since September 2012-2026/4/7
2026-04-08查看详情 > -
Page: Product-specific bioequivalence guidance-2026/5/19
2026-05-20查看详情 > -
Regulatory and procedural guideline: Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA-2022/12/12
2022-12-13查看详情 > -
国家药监局药审中心关于发布《新药获益-风险评估技术指导原则》的通告（2023年第36号）-2023/6/25
2023-06-26查看详情 >
