The CTA/CTN split
CTA for higher-risk trials (30-working-day first-cycle review) vs. CTN notification for lower-risk — under the HBRA ethics framework.
Free field guide · PDF
Singapore HSA: Clinical Trials2026 Field Guide
The CTA/CTN split, the SAR registration window, and the dossier — with the HSA practice you need.
- CTA review
- 30 days
- SAR window
- Dec 2026
- Dossier format
- CSDT
Sourced from verified 2026 publications.
Download the free guide
Enter your work email and we'll send the PDF straight to your inbox.
What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The SAR registration window
The Aug 2026 Registration Support Initiative: SAR-to-registration with waived evaluation fees — inaugural window closes Dec 31, 2026.
The dossier
MEDICS portal, ASEAN CSDT format, local Registrant, QMS evidence, and parallel dealer-licence filing.
Sources & scope
- pharmavibes.co.uk, International regulatory news in brief (Sep 2026).
- lifebit.ai, Singapore Clinical Data: Fast-Track Access.
- operonstrategist.com, Wearable Medical Device Registration in Singapore: HSA Guide.
This guide is market-access intelligence, not regulatory or legal advice. HSA trial requirements, registration windows, and dossier rules change — professional review is required before business use.
Market Access Strategy Session
Singapore on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your HSA route — CTA/CTN positioning, the SAR registration window, and dossier strategy.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team