Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

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Download document Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
Reference number EMEA/CHMP/BMWP/32775/2005 Rev. 2
Status draft: consultation open
First published 30/04/2014
Last updated 30/04/2014
Consultation start date 30/04/2014
Consultation end date 31/07/2014
Email address for submissions bmwp.secretariat@ema.europa.eu

Summary

This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming to be similar to another one already authorised (the reference medicinal product).