Chemistry of active substances (chemistry of new active substances) - Scientific guideline

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

AdoptedLegal effective date: 21/01/2017Reference Number: EMA/454576/2016Summary:

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.

Document history

Concept paper on the revision of the guideline on the chemistry of active substances - Revision 1

Consultation dates: 26/07/2022 to 31/10/2022Draft: consultation closedReference Number: EMA/CHMP/600383/2022

Guideline on the chemistry of active substances

AdoptedLegal effective date: 21/01/2017Reference Number: EMA/454576/2016Summary:

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.

Overview of comments received on 'Draft guideline on the chemistry of active substances’ (EMA/CHMP/QWP/96664/2015)

Reference Number: EMA/454577/2016Summary:

Overview of comments received on 'Draft guideline on the chemistry of active substances’ (EMA/CHMP/QWP/96664/2015)

Draft guideline on the chemistry of active substances (human)

Consultation dates: 24/04/2015 to 24/10/2015Draft: consultation closedReference Number: EMA/CHMP/QWP/96664/2015Summary:

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.

Concept paper on the need for a single note for guidance on the chemistry of active substances

Consultation dates: 10/02/2014 to 10/08/2014Draft: consultation closedReference Number: EMA/CHMP/QWP/752676/2013

Chemistry of active substances - Superseded document

AdoptedLegal effective date: 01/10/2015Reference Number: 3AQ5A

Chemistry of new active substances - Superseded document

AdoptedLegal effective date: 01/02/2004Reference Number: CPMP/QWP/130/96 Rev. 1