Criteria to be considered for the evaluation of new active substance (NAS) status of biological substances

This reflection paper 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 Decentralised Procedures-Human  (CMDh) on New Active Substance (NAS) in the context of scientific advice and assessment of Marketing Authorisation Applications (MAA).

It applies to all types of procedures for submission of a MAA, i.e. Centralised Procedure (CP), Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP) and purely national procedures for biological and biotechnology-derived medicinal products for human use.

Keywords: New active substance, NAS, biologic, ATMPs, notice to applicants 

Current version

Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances

Draft: consultation closed Consultation dates: 18/11/2022 to 31/05/2023 Reference Number: EMA/CHMP/CMDh/CAT/BWP/828612/2022 Summary:

This reflection paper 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 Decentralised Procedures-Human  (CMDh) on New Active Substance (NAS) in the context of scientific advice and assessment of Marketing Authorisation Applications (MAA).

It applies to all types of procedures for submission of a MAA, i.e. Centralised Procedure (CP), Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP) and purely national procedures for biological and biotechnology-derived medicinal products for human use.