Replaces: CPMP/EWP/560/95 (adopted by TGA 19 April 2001), and EMEA/CHMP/EWP/297931/2008 Concept Paper on this topic (provided for information 10 February 2009)
Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics
TGA Annotations: Nil
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.
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