Quality of oral modified release products - Scientific guidelines

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

Current effective version

Guideline on quality of oral modified-release products

Adopted Reference Number: EMA/CHMP/QWP/428693/2013

Document history

Guideline on quality of oral modified-release products

Adopted Reference Number: EMA/CHMP/QWP/428693/2013

Overview of comments received on 'guideline on quality of oral modified-release products'

Reference Number: EMA/CHMP/QWP/428694/2013

Draft guideline on quality of oral modified-release products

Draft: consultation closed Consultation dates: 15/09/2012 to 15/03/2013 Reference Number: EMA/492713/2012 Summary:

This guideline, together with the guideline on quality of transdermal patches, replaces the note for guidance on modified-release products: A: oral dosage forms B: transdermal dosage forms: part I (quality).

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note for guidance on quality of modified release oral dosage forms and transdermal dosage forms: Section I (quality) - Superseded

Draft: consultation closed Consultation dates: 24/06/2010 to 31/10/2010 Reference Number: EMA/CHMP/QWP/202350/2010

Note for guidance on quality of modified release products: A: oral dosage formsB: transdermal dosage forms section I (quality) - Superseded

Adopted Reference Number: CPMP/QWP/604/96 Legal effective date: 01/01/2000