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关于公开征求《细胞外囊泡药物申报临床试验药学研究的问答文件（征求意见稿）》意见的通知-2026/5/27
2026-05-28查看详情 > -
国家药监局关于修订氢化泼尼松注射液、盐酸哌替啶注射液说明书的公告（2022年第122号）-2022/12/29
2022-12-30查看详情 > -
国家药监局关于49批次药品不符合规定的通告（2023年第30号）-2023/7/17
2023-07-21查看详情 > -
Draft Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products-2024/1/29
2024-02-05查看详情 > -
Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities-2025/1/29
2025-02-05查看详情 > -
Document: Frequently asked questions (FAQs) : How to create and submit an annual safety report and respond to related requests for information - CTIS Training Programme - Module 18-2025/3/5
2025-03-06查看详情 > -
Document: ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b－2025/4/9
2025-04-11查看详情 > -
Document: Agenda - PDCO agenda of the 20-23 May 2025 meeting-2025/5/20
2025-05-21查看详情 > -
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions-2025/6/27
2025-06-27查看详情 > -
Page: Rilpivirine product-specific bioequivalence guidance-2025/7/30
2025-07-31查看详情 >
