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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Draft Guidance: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1)-2023/9/15
2023-09-19查看详情 > -
CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process-2025/1/7
2025-01-07查看详情 > -
Page: Medicines for human use under evaluation-2025/2/10
2025-02-11查看详情 > -
Document: Analysis and summaries of public consultation results: The European medicines agencies network strategy to 2028-2025/3/18
2025-03-19查看详情 > -
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 >
