Quality of oral modified release products

Current effective version

PDF iconAdopted guideline

Reference number EMA/CHMP/QWP/428693/2013
Published 31/07/2014
Effective from 01/02/2015
Keywords Oral dosage form, modified release
Description This document concerns quality aspects of dosage forms in which the release of active substance is modified. It only covers prolonged release oral dosage forms and delayed release oral dosage forms with the principle of gastro-resistance.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/02/2015–present


Published: 16/12/2014


Published: 14/08/2012

Superseded document

PDF iconConcept paper


PDF iconAdopted guideline

Published: 30/07/2010


In operation: 01/01/2000–31/01/2015

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