Chemistry of active substances (chemistry of new active substances)
Table of contents
Keywords | Active substance, chemistry, dossier, manufacture, quality control, impurities, specification |
Description | 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. |
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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Chemistry of active substances - Superseded document (PDF/36.37 KB)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Chemistry of new active substances - Superseded document (PDF/207.78 KB)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