|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|
|Consultation start date||30/04/2014|
|Consultation end date||31/07/2014|
|Email address for email@example.com|
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).