Chemistry of active substances (chemistry of new active substances)

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Current effective version

Adopted guideline

Reference numberEMA/454576/2016
Effective from21/05/2017
KeywordsActive substance, chemistry, dossier, manufacture, quality control, impurities, specification
DescriptionThis 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

Adopted guideline




Overview of comments


Draft guideline

Concept paper


Published: 21/11/2016


Effective from: 21/05/2017


Published: 21/11/2016


Published: 24/04/2015

Published: 10/02/2014

Superseded documentAdopted guideline (new active substance)In operation: 01/02/2004-21/05/2017
Superseded document Adopted guideline (active substance)In operation: 01/10/1987-21/05/2017

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