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Guideline on clinical evaluation of diagnostic agents
[PDF, 110.37 KB]
About this guideline
Overseas effective date: 1 February 2010
Replaces: CPMP/EWP/1119/98
Note: Appendix 1 to this guideline can be accessed at Appendix 1 to the Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98 Rev. 1) on imaging agents (EMEA/CHMP/EWP/321180/2008)
Categories: Clinical efficacy and safety | General (clinical) | Clinical efficacy and safety | Radiopharmaceuticals and diagnostic agents
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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For more information see International scientific guidelines adopted in Australia.