What is Required in Order to Get the Authorities to Approve a New Contrast Medium?
The evaluation of diagnostic agents is governed by the same regulatory rules and principles as those for other medicinal products. This chapter summaries relevant sections of the Guideline on Clinical Evaluation of Diagnostic Agents issued by the EMEA (2010). The requirements for authorization for completely new contrast agents may differ from those for contrast agents similar to contrast agents which have already been approved.
KeywordsContrast Agent Diagnostic Performance Medicinal Product Marketing Authorization Gadopentetate Dimeglumine
- EMEA (2010) The guideline on clinical evaluation of diagnostic agents. EMEA.Doc. Ref. CHMP/EWP/1119/98/Rev.1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003580.pdf. Accessed 1 Feb 2010