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Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes-2025/2/5
2025-02-10查看详情 > -
国家药监局关于暂停进口KYOWA HAKKO BIO CO.,LTD.谷胱甘肽等5个原料药的公告（2025年第26号）-2025/3/16
2025-03-17查看详情 > -
Page: Fees payable to the European Medicines Agency: Fees, charges and remuneration for assessment procedures and services relating to medicinal products for human use-2025/4/15
2025-04-16查看详情 > -
国家药监局药审中心关于发布“儿童抗肿瘤药物研发鼓励试点计划（星光计划）”的通知-2025/5/29
2025-05-30查看详情 > -
国家药监局综合司公开征求《医疗器械出口销售证明管理规定（修订草案征求意见稿）》意见-2025/7/2
2025-07-03查看详情 > -
Document: Public call for expression of interest for experts to become members of the European Medicines Agency's Scientific Advisory Group on Immune and Inflammatory Diseases-2025/8/5
2025-08-06查看详情 > -
Document: Mandate and objectives for the Working Group of the MSSG on the Vulnerability Analysis Methodology-2025/9/24
2025-09-25查看详情 > -
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies-2025/10/29
2025-10-31查看详情 > -
国家药监局关于注销硬性角膜接触镜等9个医疗器械注册证书的公告（2025年第114号）-2025/12/1
2025-12-02查看详情 > -
国家药监局药审中心关于发布《已上市中药变更药品说明书中安全性内容的申报资料撰写要求》的通告（2025年第56号）-2026/1/4
2026-01-05查看详情 >
