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Page: ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline-2025/7/25
2025-07-27查看详情 > -
国家药监局关于优化创新药临床试验审评审批有关事项的公告(2025年第86号)-2025/9/12
2025-09-12查看详情 > -
Page: Frequently asked questions about parallel distribution-2025/10/15
2025-10-16查看详情 > -
Page: Search tips-2025/11/19
2025-11-20查看详情 > -
Page: Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group-2025/12/15
2025-12-16查看详情 > -
Page: List of medicines under additional monitoring-2026/1/28
2026-01-29查看详情 > -
Page: ICH E2D post-approval safety data management - scientific guideline-2026/3/6
2026-03-09查看详情 > -
Page: PRAC recommendations on safety signals-2026/4/7
2026-04-08查看详情 > -
Guidance: Pulmonary Tuberculosis: Developing Drugs for Treatment (Draft)-2022/12/14
2022-12-15查看详情 > -
关于公开征求《自体CAR-T细胞治疗产品药学变更研究问题与解答(征求意见稿)-2023/6/26
2023-06-27查看详情 >