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Page: ICH M15 guideline on general principles for model-informed drug development - Scientific guideline-2026/2/11
2026-02-12查看详情 > -
Document: Qualification opinion for Molecule-independent device bridging approach (MIDBA)-2026/3/20
2026-03-23查看详情 > -
Document: Advice request: Template for applicants for breakthrough medical devices pilot-2026/4/24
2026-04-27查看详情 > -
国家药监局关于暂停进口、销售和使用GlaxoSmithKline（Ireland）Limited度他雄胺软胶囊的公告（2022年第96号）-2022/10/31
2022-11-14查看详情 > -
国家药监局药审中心关于发布《药物临床试验期间安全性信息汇总分析和报告指导原则（试行）》的通告(2023年第16号)-2023/03/17
2023-03-17查看详情 > -
Draft Guidance: Regulatory Considerations for Prescription Drug Use-Related Software-2023/9/18
2023-09-19查看详情 > -
Page: Certification of medicinal products-2025/1/6
2025-01-07查看详情 > -
Page: Product-specific bioequivalence guidance-2025/2/10
2025-02-11查看详情 > -
Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23-2025/3/18
2025-03-19查看详情 > -
Document: Template for late submission of ICSRs to EV-2025/4/22
2025-04-23查看详情 >
