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Document: Applications for new human medicines under evaluation: April 2026-2026/4/14
2026-04-15查看详情 > -
关于将TL118颗粒纳入“儿童抗肿瘤药物研发鼓励试点计划(星光计划)”试点项目的通知-2026/5/29
2026-05-31查看详情 > -
Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (updated)-2023/01/27
2023-01-27查看详情 > -
Regulatory and procedural guideline: Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group (updated)-2023/7/31
2023-08-02查看详情 > -
国家药监局综合司关于同意北京市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〔2024〕90号-2024/3/1
2024-03-12查看详情 > -
Page: Qualification of non-mutagenic impurities - Scientific guideline-2025/2/3
2025-02-05查看详情 > -
关于公开征求《化学仿制药参比制剂目录(第九十一批)》(征求意见稿)意见的通知-2025/3/12
2025-03-13查看详情 > -
Document: Overview of NCAs participating in the voluntary Simultaneous National Scientific Advice (SNSA) project-2025/4/11
2025-04-13查看详情 > -
Document: Timetable: Type II variation and worksharing application weekly assessment-2025/5/23
2025-05-26查看详情 > -
Page: Lurasidone product-specific bioequivalence guidance-2025/6/30
2025-07-01查看详情 >