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
Current effective version
Guideline on the chemistry of active substances
Guideline concerning the application of Directive 2001/83/EC with a view to the granting of a marketing authorisation for a medicinal product. This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline.
English (EN) (203.56 KB - PDF)
Document history
Concept paper on the revision of the guideline on the chemistry of active substances - Revision 1
English (EN) (117.02 KB - PDF)
Guideline on the chemistry of active substances
Guideline concerning the application of Directive 2001/83/EC with a view to the granting of a marketing authorisation for a medicinal product. This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline.
English (EN) (203.56 KB - PDF)
Overview of comments received on 'Draft guideline on the chemistry of active substances’ (EMA/CHMP/QWP/96664/2015)
Overview of comments received on 'Draft guideline on the chemistry of active substances’ (EMA/CHMP/QWP/96664/2015)
English (EN) (751.12 KB - PDF)
Draft guideline on the chemistry of active substances (human)
This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline.
English (EN) (188.39 KB - PDF)
Concept paper on the need for a single note for guidance on the chemistry of active substances
English (EN) (81.29 KB - PDF)
Chemistry of active substances - Superseded document
English (EN) (36.37 KB - PDF)
Chemistry of new active substances - Superseded document
English (EN) (207.78 KB - PDF)
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