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Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)-2023/7/31
2023-08-02查看详情 > -
国家药监局综合司关于同意广东省药品检验所调整生物制品批签发证明文件授权签字人的复函 药监综药管函〔2024〕91号-2024/3/1
2024-03-12查看详情 > -
Page: Availability of medicines before and during crises-2025/2/3
2025-02-05查看详情 > -
国家药监局关于发布医疗器械临床试验项目检查要点及判定原则的公告(2025年第22号)-2025/3/12
2025-03-13查看详情 > -
Document: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changes-2025/4/11
2025-04-13查看详情 > -
Document: Timetable: Type II variation and worksharing application alternative monthly assessment-2025/5/23
2025-05-26查看详情 > -
Document: ICH E20 guideline on adaptive designs for clinical trials - Step 2b-2025/6/30
2025-07-01查看详情 > -
Document: List of EU Medicines Regulatory Agency Organisation with single and multiple LOC IDs for Product Management Services (PMS) data enrichment - Chapter 2 Annex III-2025/7/31
2025-08-01查看详情 > -
Document: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin-2025/9/19
2025-09-22查看详情 > -
Quality Management System Information for Certain Premarket Submission Reviews Draft Guidance for Industry and Food and Drug Administration Staff-2025/10/27
2025-10-28查看详情 >