Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Scientific guideline

This document describes the chemical structure and properties criteria to be taken into account by the CHMP to qualify a chemical active substance as NAS. It provides guidance on the required elements to be submitted by applicants to substantiate their claims.

Keywords: New active substance (NAS), salts, complexes, isomers, mixtures of isomers, derivative, esters and ethers

Current version

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

Adopted Reference Number: EMA/CHMP/QWP/104223/2015

Document history

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

Adopted Reference Number: EMA/CHMP/QWP/104223/2015

Overview of comments received on 'Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances'

Reference Number: EMA/839636/2015

Draft reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

Draft: consultation closed Consultation dates: 24/04/2015 to 24/07/2015 Reference Number: EMA/CHMP/QWP/104223/2015 Summary:

This reflection paper is intended to reflect the current experience of the Quality Working Party (QWP), of the Committee for Medicinal Products for Human Use (CHMP) and the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) concerning the definition of a New Active Substance (NAS) in the context of preparation of dossiers and submissions of applications for Marketing Authorisation (MAA) in the Centralised Procedure (CP), the Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP) and purely national procedures for chemical medicinal products for human use.