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Scientific guideline: ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of
2023-07-07查看详情 > -
国家药监局关于发布仿制药参比制剂目录（第七十五批）的通告（2024年第6号）-2024/1/24
2024-02-05查看详情 > -
Document: European Shortages Monitoring Platform (ESMP): National competent authority reporting templates-2025/1/29
2025-02-05查看详情 > -
Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions-2025/3/3
2025-03-04查看详情 > -
Page: Guidance on good manufacturing practice and good distribution practice: Questions and answers-2025/4/8
2025-04-09查看详情 > -
Document: Public engagement highlights 2024-2025/5/19
2025-05-20查看详情 > -
Page: Pre-authorisation guidance-2025/6/26
2025-06-27查看详情 > -
国家药监局药审中心关于发布《模型引导的罕见疾病药物研发技术指导原则》的通告（2025年第25号）-2025/7/30
2025-07-31查看详情 > -
国家药监局关于发布YY/T 1987—2025《采用脑机接口技术的医疗器械 术语》医疗器械行业标准的公告（2025年第91号）-2025/9/16
2025-09-17查看详情 > -
化妆品监督管理常见问题解答（八）-2025/10/20
2025-10-21查看详情 >
