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关于公开征求《化学仿制药参比制剂目录（第一百批）》（征求意见稿）意见的通知-2025/11/4
2025-11-05查看详情 > -
Page: Safety of medicines-2025/12/3
2025-12-04查看详情 > -
国家药监局关于进一步优化临床急需境外已上市药品审评审批有关事项的公告（2026年第3号）-2026/1/7
2026-01-08查看详情 > -
Document: ICH M15 Guideline on general principles for model-informed drug development - Step 5-2026/2/11
2026-02-12查看详情 > -
Page: Electronic product information (ePI)-2026/3/20
2026-03-23查看详情 > -
Document: Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union: development of resistance and impact on public and animal health - Revision 1-2026/4/24
2026-04-27查看详情 > -
《药品召回管理办法》政策解读-2022/10/26
2022-11-14查看详情 > -
国家药监局药审中心关于发布《化药复方药物临床试验技术指导原则》的通告(2023年第15号)-2023/03/17
2023-03-17查看详情 > -
Draft Guidance: Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence-2023/9/18
2023-09-19查看详情 > -
Document: Information package for certificates of medicinal products issued by the European Medicines Agency-2025/1/6
2025-01-07查看详情 >
