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

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Reflection paper

Reference numberEMA/CHMP/QWP/104223/2015
KeywordsNew active substance (NAS), salts, complexes, isomers, mixtures of isomers, derivative, esters and ethers
DescriptionThis 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.  

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First version

Current version

Reflection paper

Overview of comments

Draft reflection paper

Published: 19/01/2016

Published: 17/12/2015

Published: 26/03/2015

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