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 (currently under consultation)

Guideline on the chemistry of active substances - First version

AdoptedReference Number: EMA/454576/2016Legal effective date: 21/01/2017Summary:

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.

Under consultation

Draft guideline on the chemistry of active substances - Revision 1

Draft: consultation closedConsultation dates: 25/07/2024 to 31/01/2025Reference Number: EMA/321776/2024Summary:

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.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Document history

Draft guideline on the chemistry of active substances - Revision 1

Draft: consultation closedConsultation dates: 25/07/2024 to 31/01/2025Reference Number: EMA/321776/2024Summary:

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.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

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

Draft: consultation closedConsultation dates: 26/07/2022 to 31/10/2022Reference Number: EMA/CHMP/600383/2022

Guideline on the chemistry of active substances - First version

AdoptedReference Number: EMA/454576/2016Legal effective date: 21/01/2017Summary:

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) - First version

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) - First version

Draft: consultation closedConsultation dates: 24/04/2015 to 24/10/2015Reference 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 - First version

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

Chemistry of active substances - Superseded document

AdoptedReference Number: 3AQ5ALegal effective date: 01/10/2015

Chemistry of new active substances - Superseded document

AdoptedReference Number: CPMP/QWP/130/96 Rev. 1Legal effective date: 01/02/2004