HSA Singapore · April 2026 Edition
在新加坡
注册一款药品
所需的全部依据。
A working dossier on HSA's Therapeutic Product Registration —
process, readiness check, and risk register.
Issue · 2026.Ⅳ
Prepared by
新加坡生物制药·注册事务部
Singapore Biopharma Pte. Ltd.
- Guidance
- HSA/GTDR/2026-04
- Portal
- PRISM · CorpPass
- Dossier
- ACTD / ICH-CTD / eCTD v1.1
- Routes
- Full / Abridged / Verification
"A well-prepared dossier is the shortest path through HSA."
270工作日
Full Route TAT
Full evaluation turnaround
6个月
CPP 最低有效期
Eff. 30 Jul 2025
60工作日
Verification TAT
Fastest evaluation route
v1.1
SG-HSA eCTD
Mandatory format Apr 2026
Ⅰ
注册流程清单
Registration Roadmap六阶段递进流程，从产品分类到 CPP 签发，覆盖 NDA、GDA、Full / Abridged / Verification 三条评估路径。
§ 6 阶段 · 23 步骤Ⅱ
合规自评表
Readiness Self-Assessment25 题交互式问卷，覆盖产品基础、参考国获批、GMP、CTD、CMC 等 5 章节，10 分钟内判定贵司是否具备 HSA 递交条件。
§ 5 章节 · 25 项Ⅲ
合规风险点
Compliance Risk Register依据 2026 年 4 月 HSA 最新指南梳理的 20 项潜在风险，按资质、文档、数据、标签、变更、特殊成分、IP 七维分级。
§ 7 维度 · 20 项Ⅳ
权威知识库
Authoritative Knowledge Base45 条结构化规则，源于 HSA 指南 2026/04 版 (171 pp.) 与官网更新。自评结论逐项链接至官方章节与阈值。
§ 45 规则 · 8 领域What's New · 2026 要点
2026 年 HSA
注册监管变动纪要
Key regulatory shifts effective this year — issued by HSA on 16 Jan and 1 Apr 2026.
01 Apr 2026
eCTD 正式启用
SG-HSA eCTD v1.1 becomes the official dossier standard.
01 Jun 2026
CMC 质量缺陷声明函
Applicants must declare no known CMC quality defects at submission.
16 Jan 2026
基础药 GDA 通道
Standard essential medicines may register via GDA with prior EOI.
16 Jan 2026
MAV-1 并发上限取消
Previous 3-application cap for concurrent MAV-1 lifted.
16 Jan 2026
专家利益冲突声明
Expert clinician opinions now require written COI declaration.
30 Jul 2025
CPP 剩余有效期 ≥ 6 个月
CPP must have at least six months' validity at submission.