Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form

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Document details

Download document Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form
Reference number EMA/CHMP/QWP/324350/2013
Status draft: consultation open
First published 04/07/2013
Last updated 04/07/2013
Consultation start date 04/07/2013
Consultation end date 31/12/2013
Email address for submissions qwp@ema.europa.eu

Summary

This concept paper addresses the need to update and revise the note for guidance on manufacture of the finished dosage form. This guideline was originally adopted in September 1995 and came into operation on 1 April 1996. Since then, the references to directives and the format of the dossier have been changed, and new guidance has been developed. Also the manufacture of the finished dosage form has spread worldwide and terms like holding time and bulk product are now important part of the description of the manufacturing process.