10 分钟内判定
贵司是否具备
HSA 递交条件
A structured 25-item readiness check across five chapters. Your responses are kept locally in this browser only.
产品基础信息
Product fundamentals — composition, dosage form, classification
Product category
Note中成药 (CPM) 与保健品 (HS) 走独立通报路径，非 NDA/GDA 评估范围。
Dosage form
Active ingredients & strength
Forensic classification
NotePOM = 处方药 · P = 药房专售 · GSL = 一般销售名单
Animal / human-origin ingredients
NoteTriggers Appendix 8/9 of HSA Guidance — additional safety dossier required.
已有注册证 / 上市记录
Existing approvals — determines evaluation route
Approvals in HSA reference agencies
Note≥1 个 → Abridged 路径；≥2 个 (含主要参考国) → Verification 路径。
CPP availability
NoteEffective from 30 Jul 2025 — CPP must have ≥ 6 months remaining at submission.
Years on market globally
GMP 与生产合规
Manufacturing compliance & site qualification
DS site GMP status
DP site GMP status
Recent regulatory inspection records
DP site consistent with reference-country product
档案编制状态 (CTD)
Dossier preparation — ACTD / ICH CTD / eCTD
Dossier format
Note2026 年 4 月 1 日起 SG-HSA eCTD v1.1 正式接受，强烈推荐。
Module 3 (CMC) completeness
Stability covers ASEAN Zone IVb
Module 2 summaries ready
BE study with HSA-accepted reference (GDA only)
标签、警戒与持续合规
Labelling, pharmacovigilance & post-approval readiness
English SPC & PIL drafted
SPC alignment with reference-country label
Risk Management Plan readiness
Note生物制品、首发新药、存在已知严重安全信号时必需。
Local pharmacovigilance system
Patent Declaration & Expert COI
Note2026 年 1 月 16 日起，企业聘请的专家意见需附 COI 声明。
Freedom-to-operate analysis completed
Religious-sensitive ingredients
Planned submission window
· 建议完成至少 80% 后再生成结果，以获得更准确的路径与风险判定。