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Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008-2023/02/27
2023-02-27查看详情 > -
Draft Guidance: Clinical Pharmacology Considerations for Peptide Drug Products-2023/9/8
2023-09-14查看详情 > -
Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations-2025/1/7
2025-01-07查看详情 > -
Document: Request for advice on the clinical development strategy and / or clinical investigations according to Article 61(2) of Regulation (EU) 2017/745 on from the medical device expert panels-2025/2/10
2025-02-11查看详情 > -
Page: Assessment templates and guidance-2025/3/17
2025-03-18查看详情 > -
国家药监局药审中心关于发布《简化港澳已上市传统口服中成药内地上市注册审批申报资料及技术要求》的通告（2025年第18号）-2025/4/18
2025-04-21查看详情 > -
Page: PRAC recommendations on safety signals-2025/6/2
2025-06-03查看详情 > -
Document: Procedural guidance to scientific committeesꞌ members and experts on completing the European Medicines Agencyꞌs declaration of interests in the Experts Management Tool-2025/7/4
2025-07-07查看详情 > -
Page: Vaccine Monitoring Platform-2025/8/7
2025-08-10查看详情 > -
Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations-2025/9/24
2025-09-25查看详情 >
