EMA Tackles How To Substantiate New Active Substance Claims For Biologics & ATMPs

The European Medicines Agency is seeking feedback on its position on assessing whether biological substances and advanced therapy medicinal products qualify for NAS status.

Gene therapies are among the products addressed in the new paper on NAS status • Source: Shutterstock

A biological active substance derived by recombinant DNA technology would not automatically be granted the status of a new active substance (NAS) if a version of the active substance derived from a natural source was already present in an EU authorized medicinal product.

This is just one of points addressed in a draft reflection paper from the European Medicines Agency that describes the...