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

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Current version

Reflection paper

Reference numberEMA/CHMP/QWP/104223/2015
Published19/01/2016
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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