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Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products(…)-2023/01/31
2023-01-31查看详情 > -
国家药监局综合司公开征求《国家药监局锝标记及正电子类放射性药品检验机构评定程序 （征求意见稿）》意见-2023/8/25
2023-08-28查看详情 > -
Draft Guidance: Early Alzheimer’s Disease: Developing Drugs for Treatment-2024/3/11
2024-03-12查看详情 > -
国家药监局药审中心关于发布《生物类似药说明书撰写技术指导原则》的通告（2025年第12号）-2025/2/7
2025-02-10查看详情 > -
Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants-2025/3/12
2025-03-13查看详情 > -
Page: Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline-2025/4/14
2025-04-15查看详情 > -
Document: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union-2025/5/28
2025-05-29查看详情 > -
Document: Declaration on the qualification of an enterprise as a micro, small or medium-sized enterprise (SME)-2025/7/1
2025-07-02查看详情 > -
Document: List of industry subject matter experts and list of planned calls for industry subject matter experts-2025/8/4
2025-08-05查看详情 > -
Document: Engineered living materials for in situ production of therapeutics - EU-IN Horizon Scanning Report-2025/9/23
2025-09-24查看详情 >
