The two schemes
CTN vs. CTA: notification after HREC approval, or formal application with data for TGA evaluation — plus the 28-day Part 2 rule.
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Australia TGA: Clinical Trials2026 Field Guide
The two schemes, the E6(R3) transition, and the trial start line — with the TGA practice you need.
- Schemes
- 2
- E6(R3) live
- Jan 2026
- Part 2 window
- 28 days
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The E6(R3) transition
TGA adopted ICH GCP E6(R3) on 13 January 2026 with a 12-month transition — what sponsors and sites must update.
The trial start line
Ethics first, then TGA: the 2026 pattern for starting Australian trials, and how GHMAP pairs evidence with market access.
Sources & scope
- tga.gov.au, Clinical Trials and Good Clinical Practice (GCP) (Jul 2026).
- tga.gov.au, CTA scheme Part 1 form (Supply of unapproved therapeutic goods under the CTA scheme).
- investegate.co.uk, TheraCryf PLC Australian partner to progress Ox-1 Phase 1 trial (2 Oct 2026).
This guide is market-access intelligence, not regulatory or legal advice. TGA trial schemes, GCP requirements, and ethics processes change — professional review is required before business use.
Market Access Strategy Session
Australia trials on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your evidence route — CTN vs. CTA positioning, site selection, and market-access pairing.
Professional review is required before business use.
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