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抗肿瘤抗体偶联药物临床研发技术指导原则-2023/4/7
2023-04-10查看详情 > -
关于公开征求《注射用醋酸亮丙瑞林微球生物等效性研究技术指导原则(征求意见稿)》意见的通知-2023/10/08
2023-10-08查看详情 > -
Document: PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC meeting-2025/1/7
2025-01-08查看详情 > -
Page: Overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Scientific guideline-2025/2/13
2025-02-14查看详情 > -
国家药监局 国家卫生健康委关于颁布2025年版《中华人民共和国药典》的公告(2025年第29号)-2025/3/25
2025-03-26查看详情 > -
国家药监局关于暂停进口VITAL LABORATORIES PVT. LTD.地高辛原料药的公告(2025年第43号)-2025/4/27
2025-04-28查看详情 > -
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs Draft -2026/6/4
2025-06-06查看详情 > -
Document: Review of artificial intelligence and machine learning applications in medicines lifecycle 2024: Horizon Scanning Short Report-2025/7/10
2025-07-11查看详情 > -
关于公开征求《单臂临床试验用于支持抗肿瘤药物常规上市申请技术指导原则(征求意见稿)》意见的通知-2025/8/20
2025-08-21查看详情 > -
Page: Clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF) - Scientific guideline-2025/9/30
2025-10-08查看详情 >