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ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline-2023/02/07
2023-02-07查看详情 > -
国家药监局关于修订琥珀酰明胶注射液说明书的公告(2023年第113号)-2023/8/29
2023-09-01查看详情 > -
Draft Guidance: Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products-2024/3/12
2024-03-15查看详情 > -
关于将乙磺酸尼达尼布软胶囊纳入《以患者为中心的罕见疾病药物研发试点工作计划(“关爱计划”)》试点项目的公示-2025/2/9
2025-02-10查看详情 > -
国家药监局关于调整国家药监局化妆品标准化技术委员会委员的公告(2025年第27号)-2025/3/13
2025-03-14查看详情 > -
Page: Non-clinical Working Party-2025/4/15
2025-04-16查看详情 > -
Document: Annex to 27-30 January 2025 CHMP Minutes-2025/5/28
2025-05-29查看详情 > -
Page: Ibuprofen product-specific bioequivalence guidance-2025/7/1
2025-07-02查看详情 > -
关于公开征求《关于开发适宜药品包装规格的指导原则》意见的通知-2025/8/5
2025-08-06查看详情 > -
Document: Timetable: Post-authorisation safety study (PASS) protocols and final results-2025/9/23
2025-09-24查看详情 >