Chemistry of active substances (chemistry of new active substances)
Table of contents
This document describes the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product.
Keywords: Active substance, chemistry, dossier, manufacture, quality control, impurities, specification
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Guideline on the chemistry of active substances (PDF/203.56 KB)
Adopted
First published: 21/11/2016
Last updated: 21/11/2016
Legal effective date: 21/01/2017
EMA/454576/2016 -
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Overview of comments received on 'Draft guideline on the chemistry of active substances’ (EMA/CHMP/QWP/96664/2015) (PDF/751.12 KB)
First published: 21/11/2016
Last updated: 21/11/2016
EMA/454577/2016 -
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Draft guideline on the chemistry of active substances (human) (PDF/188.39 KB)
Draft: consultation closed
First published: 24/04/2015
Last updated: 24/04/2015
Consultation dates: 24/04/2015 to 24/10/2015
EMA/CHMP/QWP/96664/2015 -
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Concept paper on the need for a single note for guidance on the chemistry of active substances (PDF/81.29 KB)
Draft: consultation closed
First published: 10/02/2014
Last updated: 10/02/2014
Consultation dates: 10/02/2014 to 10/08/2014
EMA/CHMP/QWP/752676/2013 -
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Chemistry of active substances - Superseded document (PDF/36.37 KB)
Adopted
First published: 01/10/2015
Last updated: 01/10/2015
Legal effective date: 01/10/2015
3AQ5A -
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Chemistry of new active substances - Superseded document (PDF/207.78 KB)
Adopted
First published: 17/12/2003
Last updated: 17/12/2003
Legal effective date: 01/02/2004
CPMP/QWP/130/96 Rev. 1