首页 >
法规速递
-
Document: User manual for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) user interface (XEVMPDweb)-2026/7/10
2026-07-11查看详情 > -
Determining Whether to Submit an ANDA or a 505(b)(2) Application-2026/8/17
2026-08-18查看详情 > -
Scientific guideline: ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5-2023/01/06
2023-01-06查看详情 > -
国家药监局药审中心关于发布 《以患者为中心的药物临床试验设计技术指导原则（试行）》《以患者为中心的药物临床试验实施技术指导原则（试行）》《以患者为中心的药物获益-风险评估技术指导原则（试行）》的通告（2023年第44号）-2023/7/27
2023-07-28查看详情 > -
国家药监局 海关总署关于增设合肥空港口岸为药品进口口岸的公告（2024年第12号）-2024/2/6
2024-03-11查看详情 > -
Document: Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues-2025/1/31
2025-02-05查看详情 > -
Document: European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for national competent authorities (NCAs) (JSON) (YAML)-2025/3/10
2025-03-11查看详情 > -
Document: Innovation Task Force (ITF) briefing meeting request form-2025/4/10
2025-04-11查看详情 > -
Page: ICH E6 Good clinical practice - Scientific guideline-2025/5/23
2025-05-26查看详情 > -
Document: PRAC recommendations on signals adopted at the 2-5 June 2025 PRAC meeting-2025/6/30
2025-07-01查看详情 >
