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Document: Quality Review of Documents (QRD) working group plenary meeting dates-2025/12/16
2025-12-17查看详情 > -
Document: Agenda - PCWP and HCPWP joint meeting February 2026-2026/1/30
2026-02-02查看详情 > -
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)-2026/3/9
2026-03-10查看详情 > -
Document: CHMP PROM minutes for the meeting on 6 October 2025-2026/4/8
2026-04-09查看详情 > -
国家药监局药审中心关于发布《同名同方药研究技术指导原则（试行）》的通告(2022年第48号)-2022/12/27
2022-12-29查看详情 > -
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 >
