EMA releases insulin medicine guidelines

Published: 24-Mar-2015
Regulatory

The guidance looks at in vitro pharmacodynamic study requirements


The European Medicines Agency (EMA) has released guidelines on assessing whether biological medicinal products containing insulin and insulin analogues can be deemed similar to authorised medicines, hence bypassing certain regulatory controls.

The guidance looks at in vitro pharmacodynamic study requirements and advises when extra in vivo toxicological assessments might be needed.

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