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

Current version

PDF iconReflection paper

Reference number EMA/CHMP/QWP/104223/2015
Published 19/01/2016
Keywords New active substance (NAS), salts, complexes, isomers, mixtures of isomers, derivative, esters and ethers
Description 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.


Document history

First version

Current version

PDF iconReflection paper

 

PDF iconOverview of comments

 

PDF iconDraft reflection paper

Published: 19/01/2016

 

Published: 17/12/2015

 

Published: 26/03/2015


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