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关于公开征求《基因治疗血友病临床试验设计技术指导原则（征求意见稿）》意见的通知-2022/10/9
2022-11-14查看详情 > -
国家药监局药审中心关于发布《化学药品创新药Ⅲ期临床试验前会议药学共性问题及相关技术要求（试行）》的通告（2023年第23号）-2023/03/24
2023-03-24查看详情 > -
国家药监局药审中心关于发布《干眼治疗药物临床试验技术指导原则》的通告（2023年第50号）-2023/9/28
2023-10-07查看详情 > -
Page: Plasma master file certificates-2025/1/6
2025-01-07查看详情 > -
Page: Nilotinib product-specific bioequivalence guidance-2025/2/12
2025-02-13查看详情 > -
Page: Opinions and letters of support on the qualification of novel methodologies for medicine development-2025/3/20
2025-03-21查看详情 > -
Document: Business process description for sampling and testing of CAPs-2025/4/22
2025-04-23查看详情 > -
Document: Questions and answers on the refusal of the marketing authorisation for Atropine sulfate FGK (atropine sulfate)-2025/6/3
2025-06-04查看详情 > -
Document: Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1-2025/7/10
2025-07-11查看详情 > -
Document: CHMP PROM minutes for the meeting on 17 February 2025-2025/8/14
2025-08-15查看详情 >
