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IPQ Inside the global regulatory dialogue

New Active Substance Guide

Feb 22nd, 2016

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EMA has released a reflection paper on “the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances.”  The paper describes the chemical structure and properties criteria to be taken into account by the Committee for Medicinal Products for Human Use (CHMP) to qualify a chemical active substance as an NAS, as well as the required elements to be submitted by applicants to substantiate their claims.  The bulk of the seven-page paper provides discussion of and guidance regarding how the committee will determine the NAS status of: ● isomers ● mixtures of isomers ● complexes ● derivatives ● esters and ethers ● salts, and ● solid state forms.  Biological and biotechnological active substances and active substances to be included in radiopharmaceutical medicinal products are excluded from the scope of the paper.  Other than minor modifications and clarifications, the paper is largely unchanged from a draft circulated for a 90-day comment period beginning in April 2015 (IPQ May 31, 2015).

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