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European Medicines Agency public consultation – reflection paper

The European Medicines Agency has published for public consultation a reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances. 

This document describes the current scientific thinking applied to New Active Substance (NAS) assessment of biological active substances and provides guidance on the elements required to be submitted by applicants to substantiate a NAS claim. Advanced Therapy Medicinal Products (ATMPs) are within the scope of this document. 

The different considerations that apply to the NAS assessment of active substances in this class of products are presented separately. Chemical active substances and radiopharmaceutical medicinal products are excluded from the scope of this reflection paper. 

Comments should be sent to [email protected] by 31 May 2023. 

The reflection paper and the template to provide comments is available here.