|Download document||Second 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. 1|
|Status||draft: consultation closed|
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).