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国家药监局药审中心关于发布《临床试验中的药物性肝损伤识别、处理及评价指导原则》的通告(2023年第39号)-2023/7/10
2023-07-10查看详情 > -
国家药监局药审中心关于发布《放射性治疗药物非临床研究技术指导原则》的通告(2024年第9号)-2024/1/24
2024-02-05查看详情 > -
Document: List of medicinal products under additional monitoring-2025/1/29
2025-02-05查看详情 > -
Page: CHMP opinions on consultation procedures-2025/3/5
2025-03-06查看详情 > -
Page: Real-world evidence-2025/4/8
2025-04-09查看详情 > -
Document: Standard operating procedure for validation, publication, and maintenance of real-world data sources and studies in the HMA-EMA RWD Catalogues-2025/5/19
2025-05-20查看详情 > -
Unique Device Identifier Requirements for Combination Products-2025/6/25
2025-06-27查看详情 > -
Page: Sitagliptin product-specific bioequivalence guidance-2025/7/30
2025-07-31查看详情 > -
Page: Mpox-2025/9/16
2025-09-17查看详情 > -
Page: Development of new medicinal products for the treatment of ulcerative colitis - Scientific guideline-2025/10/22
2025-10-23查看详情 >