We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
TGA has adopted the following 3 international scientific guidelines:
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
- Guideline on quality documentation for medicinal products when used with a medical device.
- Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.
Enquiries
For enquiries relating to the consultation please email isguidelines@health.gov.au.
