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Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (Draft)-2022/11/1
2022-11-30查看详情 > -
Draft Guidance: Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations-2023/5/17
2023-05-18查看详情 > -
国家药监局药审中心关于发布《自体CAR-T细胞治疗产品药学变更研究的问题与解答》的通告-2023/11/16
2023-11-20查看详情 > -
Document: Iodine (131i) iobenguane : List of nationally authorised medicinal products - PSUSA/00001764/202405-2025/1/16
2025-01-17查看详情 > -
Document: Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 26 February 2025-2025/2/21
2025-02-24查看详情 > -
Page: Electronic product information (ePI)-2025/3/31
2025-04-01查看详情 > -
关于公开征求《化学仿制药参比制剂目录（第九十三批）》（征求意见稿）意见的通知-2025/5/7
2025-05-08查看详情 > -
Document: Orientation guide for industry - EMA building-2025/6/16
2025-06-17查看详情 > -
Page: Pharmaceutical quality of inhalation and nasal products - Scientific guideline-2025/7/21
2025-07-22查看详情 > -
国家药监局药审中心关于发布《抗体偶联药物临床药理学研究技术指导原则》的通告（2025年第34号）-2025/9/8
2025-09-09查看详情 >
