International scientific guideline: ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration
EMA/CHMP/ICH/308671/2008 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.