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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 > -
Document: Template for scientific document for paediatric investigation plan or product-specific waiver-2025/10/14
2025-10-15查看详情 > -
2025年11月19日中药品种保护受理公示-2025/11/19
2025-11-20查看详情 > -
关于公开征求《化学仿制药滴眼剂研究技术指导原则(征求意见稿)》和《化学仿制药特殊滴眼剂研究技术指导原则(征求意见稿)》意见的通知-2025/12/15
2025-12-15查看详情 > -
国家药监局药审中心关于发布《预防用mRNA疫苗药学研究技术指导原则(试行)》的通告(2026年第12号)-2026/1/28
2026-01-28查看详情 > -
Page: Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)-2026/3/5
2026-03-06查看详情 > -
国家药监局药审中心关于修订发布《国家药品监督管理局药品审评中心药物研发与技术审评沟通交流管理办法》的通告(2026年第28号)-2026/4/3
2026-04-05查看详情 > -
Document: Application form for the involvement of healthcare professionals’ organisations in the activities of the European Medicines Agency-2026/5/19
2026-05-20查看详情 >