Australie: Guides internationaux adoptés par TGA

La Therapeutic Goods Administration (TGA) a adopté les 3 guides scientifiques internationaux suivants:

1. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
2. Guideline on quality documentation for medicinal products when used with a medical device.
3. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.

Source : Adoption of International Scientific Guidelines in Australia – R02/2024 | Therapeutic Goods Administration (TGA)