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国家药监局综合司关于同意山东省食品药品检验研究院调整生物制品批签发证明文件授权签发人的复函 药监综药管函〔2023〕650号-2023/12/20
2023-12-21查看详情 > -
Document: Agenda of the CAT meeting 22-24 January 2025-2025/1/21
2025-01-22查看详情 > -
Page: Good manufacturing practice-2025/2/24
2025-02-25查看详情 > -
Document: Template - Request for advice on the clinical development strategy or clinical data required for the clinical evaluation pursuant to Article 61(2) or Article 106(11) of Regulation (EU) 2017/745 and MDCG 2024-10 on from the Expert Panels-2025/4/1
2025-04-02查看详情 > -
Document: IVF Media G5 - Procedural steps and scientific information after initial consultation-2025/5/12
2025-05-13查看详情 > -
Page: Epidemiological data on blood transmissible infections - Scientific guideline-2025/6/19
2025-06-20查看详情 > -
Page: Parallel scientific advice and special development aspects or product types-2025/7/24
2025-07-25查看详情 > -
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry-2025/9/8
2025-09-09查看详情 > -
Document: Agenda of the CHMP meeting 13-16 October 2025-2025/10/13
2025-10-14查看详情 > -
图解海报 | 《医疗器械生产质量管理规范》系列解读（九）-2025/11/18
2025-11-19查看详情 >
