Reflection Paper on Criteria to be Considered for the Evaluation of New Active Substance (NAS) Status of Biological Substances

18 November 2022 – EMA published draft guidance on criteria for the evaluation of NAS status of biological substances for consultation. Comments may be submitted until 31 May 2023.

This document is intended to reflect the current experience of the Biologics Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP), the Committee for Advanced Therapies (CAT), and the Co-ordination Group for Mutual Recognition and Decentralized Procedures-Human (CMDh) on New Active Substance (NAS) in the context of scientific advice and assessment of Marketing Authorization Applications (MAA). It applies to all types of procedures for submission of a MAA, i.e. Centralized Procedure (CP), Mutual Recognition Procedure (MRP)/Decentralized Procedure (DCP) and purely national procedures for biological and biotechnology-derived medicinal products for human use.

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