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国家药监局关于发布《药品经营质量管理规范附录6:药品零售配送质量管理》的公告(2022年 第113号)-2022/11/30
2022-12-01查看详情 > -
国家药监局药审中心关于发布《人源性干细胞及其衍生细胞治疗产品临床试验技术指导原则(试行)》的通告(2023年第37号)-2023/6/21
2023-06-21查看详情 > -
Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guideline-2023/12/19
2023-12-21查看详情 > -
国家药监局药审中心关于发布《疫苗说明书临床相关信息撰写指导原则(试行)》的通告(2025年第9号)-2025/1/23
2025-01-23查看详情 > -
Document: CTIS newsflash - 25 February 2025-2025/2/25
2025-02-27查看详情 > -
Document: Rules of procedure for the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP)-2025/4/2
2025-04-03查看详情 > -
Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP)-2025/5/13
2025-05-14查看详情 > -
Document: Agenda of the Medicine Shortages SPOC Working Party meeting on 17 June 2025-2025/6/20
2025-06-23查看详情 > -
Page: Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline-2025/7/25
2025-07-27查看详情 > -
Document: PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment-2025/9/10
2025-09-11查看详情 >