Clinical evaluation of diagnostic agents - Scientific guideline

This document outlines the principles for the clinical evaluation of diagnostic agents that are intended for in vivo administration.

Keywords: Diagnostic agents, imaging agents, theranostics, marketing authorisation

Current effective version (under revision, see document history)

Guideline on clinical evaluation of diagnostic agents

Adopted Reference Number: CPMP/EWP/1119/98/Rev. 1 Legal effective date: 01/02/2010

Document history - Revision 2

Concept paper on the revision of the guideline on clinical evaluation of diagnostic agents and its appendix 1 on imaging agents

Draft: consultation open Consultation dates: 30/01/2026 to 30/04/2026 Reference Number: EMA/4366/2026 Summary:

The proposed guideline will replace the Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev. 1) and the 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).

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Document history - Revision 1

Guideline on clinical evaluation of diagnostic agents

Adopted Reference Number: CPMP/EWP/1119/98/Rev. 1 Legal effective date: 01/02/2010

Overview of comments received on draft guideline on clinical evaluation of diagnostic agents

Reference Number: EMA/182470/2009

Draft guideline on clinical evaluation of diagnostic agents

Draft: consultation closed Reference Number: CPMP/EWP/1119/98/Rev 1

Recommendation for revision of the points to consider on the evaluation of diagnostic agents

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/13062/2007

Document history - First version

Points to consider on the evaluation of diagnostic agents

Adopted Reference Number: CPMP/EWP/1119/98 Legal effective date: 01/06/2002