TGA
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.
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