Chemistry of active substances (chemistry of new active substances)

Current effective version

PDF iconAdopted guideline

Reference number EMA/454576/2016
Published 21/11/2016
Effective from 21/05/2017
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.

Document history

Superseding document
Current version

PDF iconAdopted guideline




PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper


Published: 21/11/2016


Effective from: 21/05/2017


Published: 21/11/2016


Published: 24/04/2015


Published: 10/02/2014

Superseded document PDF iconAdopted guideline (new active substance) In operation: 01/02/2004-21/05/2017
Superseded document PDF iconAdopted guideline (active substance) In operation: 01/10/1987-21/05/2017

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