Guideline on clinical evaluation of diagnostic agents

We have adopted this International Scientific Guideline - CPMP/EWP/1119/98/Rev. 1.

Last updated

3 June 2024

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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