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Document: Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (27 March 2026 - 23 April 2026)-2026/5/19
2026-05-20查看详情 > -
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials (Final)-2022/12/5
2022-12-06查看详情 > -
Scientific guideline: Concept paper on the development of a guideline on the quality aspects of mRNA vaccines-2023/6/23
2023-06-25查看详情 > -
国家药监局关于修订复方首乌地黄丸说明书的公告(2023年第160号)-2023/12/27
2024-01-03查看详情 > -
国家药监局关于简化港澳已上市传统口服中成药内地上市注册审批的公告(2025年第7号) -2025/1/21
2025-01-23查看详情 > -
Page: Website outages and upgrades-2025/2/26
2025-02-27查看详情 > -
Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)-2025/4/2
2025-04-03查看详情 > -
图解海报 |《化妆品安全风险监测与评价管理办法》系列解读(二)-2025/5/14
2025-05-15查看详情 > -
Document: Instructions on how to apply for a portfolio & technology meeting (PTM)-2025/6/20
2025-06-23查看详情 > -
Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions-2025/7/25
2025-07-27查看详情 >