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Page: Everolimus product-specific bioequivalence guidance-2025/8/14
2025-08-15查看详情 > -
Document: Minutes - PDCO minutes of the 22-25 July 2025 meeting-2025/9/26
2025-09-28查看详情 > -
Document: Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568-2025/11/4
2025-11-05查看详情 > -
Document: Dengvaxia : EPAR - All authorised presentations-2025/12/4
2025-12-05查看详情 > -
Page: Substance and product data management services-2026/1/12
2026-01-13查看详情 > -
Document: Guidance for applicants for the preparation of the precise scope section of the variation application form-2026/2/12
2026-02-13查看详情 > -
国家药监局综合司关于开展医疗器械临床创新成果转化“春雨行动”的通知-2026/3/24
2026-03-25查看详情 > -
Document: Advice request: Template for applicants for breakthrough medical devices pilot-2026/4/28
2026-04-29查看详情 > -
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 >