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国家药监局药审中心关于发布《儿童用药研发常见/共性问题及一般性答复》的通告-2025/10/11
2025-10-11查看详情 > -
Document: Guidance for applicants: the ETF scientific advice that facilitates clinical trial authorisations (SA-CTA)-2025/11/17
2025-11-18查看详情 > -
中药保护品种公告(第32号)(2025年 第116号)-2025/12/12
2025-12-15查看详情 > -
Document: European Medicines Agency’s data protection notice for EudraVigilance Human (EV)-2026/1/23
2026-01-26查看详情 > -
Document: Annual report on the use of the special contribution for orphan medicinal products - 2025-2026/3/3
2026-03-04查看详情 > -
Page: Opinions and letters of support on the qualification of novel methodologies for medicine development-2026/3/3/1
2026-04-01查看详情 > -
Document: Timetable: Initial (full) marketing authorisation application accelerated assessment timetables-2026/5/13
2026-05-14查看详情 > -
Document: FAQs: Support with workload management by workspace - CTIS Training Programme - Module 04-2026/6/26
2026-06-29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-2022/11/4
2022-11-30查看详情 > -
关于公开征求ICH《E6(R3):药物临床试验质量管理规范(GCP)》指导原则及附件1草案的通知-2023/5/29
2023-05-30查看详情 >