International scientific guideline: Reflection paper on non-clinical and clinical development of similar medicinal products containing recombinant interferon alfa
EMEA/CHMP/BMWP/102046/2006 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.