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). 
 

The non-clinical section addresses the requirements of in vitro pharmacodynamic studies and cases when there is a need for additional in vivo toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic and safety studies as well as the risk management plan.

 

Posted on the EMA website on 30 April 2014