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Document: Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD)-2026/4/20
2026-04-21查看详情 > -
Page: Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline-2026/6/3
2026-06-04查看详情 > -
Scientific guideline: Guideline on plasmid DNA vaccines for veterinary use-2023/02/24
2023-02-24查看详情 > -
关于公开征求《人纤维蛋白原临床试验技术指导原则(修订版征求意见稿)》意见的通知-2023/9/4
2023-09-05查看详情 > -
国家药监局关于废止YY/T 0771.1-2020 《动物源医疗器械 第1部分:风险管理应用》和YY/T 0771.2-2020 《动物源医疗器械 第2部分:来源、收集与处置的控制》医疗器械行业标准的公告(2024年第157号)-2025/1/6
2025-01-07查看详情 > -
Page: Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guideline-2025/2/6
2025-02-10查看详情 > -
Document: Frequently asked questions (FAQs): How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10-2025/3/14
2025-03-17查看详情 > -
Page: Fees payable to the European Medicines Agency: Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices-2025/4/15
2025-04-16查看详情 > -
国家药监局综合司再次公开征求《关于加强药品受托生产监督管理工作的公告(征求意见稿)》意见 -2025/5/30
2025-05-30查看详情 > -
Document: Network Data Steering Group workplan 2025-2028-2025/7/2
2025-07-03查看详情 >