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国家药监局关于发布《血液净化体外循环系统 血液透析器、血液透析滤过器、血液滤过器及血液浓缩器用体外循环血路/液路》等10项医疗器械行业标准的公告(2025年第21号)-2025/2/28
2025-03-03查看详情 > -
Document: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes-2025/4/4
2025-04-07查看详情 > -
国家药监局关于修订盐酸雷尼替丁注射制剂说明书的公告(2025年第49号)-2025/5/16
2025-05-16查看详情 > -
Document: Article 57 product data-2025/6/24
2025-06-25查看详情 > -
Page: COVID-19 vaccines: key facts-2025/7/28
2025-07-29查看详情 > -
国家药监局药审中心关于发布《创新药研发期间风险管理计划撰写技术指导原则(试行)》的通告(2025年第38号)-2025/9/12
2025-09-12查看详情 > -
药你知道 | 《国家药监局关于发布优化全生命周期监管支持高端医疗器械创新发展有关举措的公告》系列解读(十)-2025/10/16
2025-10-17查看详情 > -
Page: Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets)-2025/11/20
2025-11-21查看详情 > -
Page: Extensions of marketing authorisations: questions and answers-2025/12/15
2025-12-16查看详情 > -
Document: Report - Highlights of the 15th Industry Standing Group (ISG) meeting-2026/1/28
2026-01-29查看详情 >