Quality of oral modified release products - Scientific guidelines
Table of contents
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.
Keywords: Oral dosage form, modified release
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Guideline on quality of oral modified-release products (PDF/187.72 KB)
Adopted
First published: 31/07/2014
Last updated: 31/07/2014
EMA/CHMP/QWP/428693/2013 -
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Overview of comments received on 'guideline on quality of oral modified-release products' (PDF/510.58 KB)
First published: 31/07/2014
Last updated: 31/07/2014
EMA/CHMP/QWP/428694/2013 -
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Draft guideline on quality of oral modified-release products (PDF/186.75 KB)
Draft: consultation closed
First published: 14/09/2012
Last updated: 14/09/2012
Consultation dates: 15/09/2012 to 15/03/2013
EMA/492713/2012 -
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Concept paper on the revision of the note for guidance on quality of modified release oral dosage forms and transdermal dosage forms: Section I (quality) - Superseded (PDF/94.71 KB)
Draft: consultation closed
First published: 30/07/2010
Last updated: 30/07/2010
Consultation dates: 24/06/2010 to 31/10/2010
EMA/CHMP/QWP/202350/2010 -
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Note for guidance on quality of modified release products: A: oral dosage formsB: transdermal dosage forms section I (quality) - Superseded (PDF/83.82 KB)
Adopted
First published: 29/07/1999
Last updated: 29/07/1999
Legal effective date: 01/01/2000
CPMP/QWP/604/96