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Regulatory and procedural guideline: IRIS guide to registration and RPIs-2022/11/21
2022-11-30查看详情 > -
关于公开征求《化学仿制药参比制剂目录（第七十批）》（征求意见稿）意见的通知-2023/6/1
2023-06-02查看详情 > -
国家药监局药审中心关于发布《药品说明书（简化版）及药品说明书（大字版）编写指南》和《电子药品说明书（完整版）格式要求》的通告（2023年第56号）-2023/11/28
2023-12-21查看详情 > -
Document: Agenda of the COMP meeting 21-23 January 2025-2025/1/21
2025-01-22查看详情 > -
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes-2025/2/24
2025-02-25查看详情 > -
Page: Handling competing interests-2025/4/1
2025-04-02查看详情 > -
Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Draft Guidance for Industry-2025/5/2
2025-05-12查看详情 > -
Document: Superseded assessment report on Zingiber officinale Roscoe, rhizoma-2025/6/19
2025-06-20查看详情 > -
Document: HMA-EMA joint Network Data Steering Group meeting 27 June 2025-2025/7/24
2025-07-25查看详情 > -
Document: Start of procedure: Extension of marketing authorisation (25 July - 21 August 2025)-2025/9/8
2025-09-09查看详情 >
