首页 >
法规速递
-
Page: Extensions of marketing authorisations: questions and answers-2025/11/26
2025-11-27查看详情 > -
Document: Technology Capability Investment Plan to 2028 - Becoming a digital hub for the European medicines regulator network-2025/12/19
2025-12-22查看详情 > -
Page: Epidemiological data on blood transmissible infections - Scientific guideline-2026/2/4
2026-02-05查看详情 > -
Document: Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients-2026/3/13
2026-03-16查看详情 > -
国家药监局药审中心关于发布《以患者为中心的中药新药临床研发技术指导原则》的通告（2026年第29号）-2026/4/13
2026-04-14查看详情 > -
Regulatory and procedural guideline: Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency (updated)-2023/01/16
2023-01-16查看详情 > -
关于公开征求《基于药代动力学方法支持用于肿瘤治疗的抗PD-1/PD-L1抗体可替换给药方案的技术指导原则（征求意见稿）》意见的通知-2023/8/1
2023-08-02查看详情 > -
国家药监局综合司关于印发药品网络交易第三方平台检查指南（试行）的通知 药监综药管函〔2023〕691号-2024/1/5
2024-03-12查看详情 > -
Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers-2025/1/31
2025-02-05查看详情 > -
Document: Presentation - Optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases: FDA guidance (Mirat Shah)-2025/3/11
2025-03-12查看详情 >
