EN PL

EMA: Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues (Rev 2)

08.05.2014
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).