首页 >
法规速递
-
Document: Guidance for stepwise PIPs (sPIPs)-2025/11/28
2025-12-01查看详情 > -
国家药监局药审中心关于发布《治疗慢性气道疾病的靶向炎症因子类生物制剂临床试验技术指导原则（试行）》的通告（2025年第51号）-2025/12/30
2025-12-31查看详情 > -
Document: Overview of (invented) names reviewed in November 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 11 December 2025-2026/2/6
2026-02-09查看详情 > -
Page: Stakeholders and Communication-2026/3/16
2026-03-17查看详情 > -
Page: Recommendations on medication errors-2026/4/16
2026-04-17查看详情 > -
医疗器械分类调整相关公告解读-2026/6/1
2026-06-02查看详情 > -
Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products(Draft)-2023/01/31
2023-01-31查看详情 > -
国家药监局综合司公开征求《药品附条件批准上市申请审评审批工作程序（试行） （修订稿征求意见稿）》意见-2023/8/25
2023-08-25查看详情 > -
国家药监局药审中心关于发布《小儿便秘中药新药临床研发技术指导原则（试行）》的通告（2024年第19号）-2024/3/1
2024-03-12查看详情 > -
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)-2025/2/5
2025-02-06查看详情 >
