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Document: Qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials-2025/4/22
2025-04-23查看详情 > -
Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)-2025/6/2
2025-06-03查看详情 > -
国家药监局关于发布仿制药参比制剂目录(第九十三批)的通告(2025年第24号)-2025/7/8
2025-07-09查看详情 > -
Page: Paediatric medicines: applications and procedures-2025/8/8
2025-08-10查看详情 > -
Page: Product-specific bioequivalence guidance-2025/9/25
2025-09-26查看详情 > -
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 >