International scientific guideline: ICH Topic Q 1 A (R2) - Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products
CPMP/ICH/2736/99 adopted by the Therapeutic Goods Administration (TGA)
Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.