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Document: Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders-2026/1/28
2026-01-29查看详情 > -
国家药监局关于发布仿制药参比制剂目录(第一百零二批)及调出参比制剂目录品种清单(第四批)的通告(2026年第7号)-2026/3/9
2026-03-10查看详情 > -
Document: CHMP PROM minutes for the meeting on 10 June 2025-2026/4/7
2026-04-08查看详情 > -
关于公开征求《<慢性乙型肝炎病毒感染治疗药物临床试验技术指导原则>问答文件(征求意见稿)》意见的通知-2026/7/6
2026-07-07查看详情 > -
Document: Annex 1 - Qualification opinion briefing book for the Big MS Data network registries on Post Authorization Safety Studies-2026/8/12
2026-08-13查看详情 > -
中药新药用于慢性胃炎的临床疗效评价技术指导原则(试行)-2022/12/21
2022-12-22查看详情 > -
关于公开征求《抗肿瘤药物说明书安全性信息撰写技术指导原则(征求意见稿)》意见的通知-2023/6/30
2023-06-30查看详情 > -
Development and manufacture of human medicinal products specifically designed for phage therapy - Scientific guideline-2023/12/22
2024-01-03查看详情 > -
Document: Product Management Service (PMS) roadmap-2025/1/24
2025-02-05查看详情 > -
Document: Minutes of the CAT meeting 22-24 January 2025-2025/2/27
2025-03-03查看详情 >