EMA: 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

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.