Draft guideline on evaluation of anticancer medicinal products in man

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Download document Draft guideline on evaluation of anticancer medicinal products in man
Reference number EMA/CHMP/205/95 Rev. 5
Status draft: consultation open
First published 15/03/2016
Last updated 15/03/2016
Consultation start date 15/03/2016
Consultation end date 15/09/2016
Email address for submissions oncwp@ema.europa.eu

Summary

The purpose of this guideline is to provide guidance on all stages of clinical drug development for the treatment of malignancies, including drug resistance modifiers or normal tissue protective compounds. Supportive measures such as anti-emetics and haematopoietic growth factors, however, are covered by separate guidelines.