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Page: Pre-authorisation guidance-2025/6/27
2025-06-30查看详情 > -
Document: Overview of comments received on the “HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application (MAA) dossier” - public consultation
2025-07-31查看详情 > -
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment-2025/9/17
2025-09-18查看详情 > -
Document: Draft guideline on quality aspects of phage therapy medicinal products-2025/10/24
2025-10-27查看详情 > -
Document: Regulatory Procedure Management in IRIS roadmap-2025/11/26
2025-11-27查看详情 > -
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices-2025/12/18
2025-12-19查看详情 > -
国家药监局药审中心关于发布《慢性失眠治疗药物临床试验技术指导原则（试行）》的通告（2026年第1号）-2026/2/4
2026-02-05查看详情 > -
Document: Minutes of the COMP meeting 20-22 January 2026-2026/3/11
2026-03-12查看详情 > -
Document: Template for sharing EMA documents by Industry to support reliance-2026/4/9
2026-04-10查看详情 > -
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)-2022/12/21
2022-12-21查看详情 >
