ICH Q8 (R2) Pharmaceutical development

Current effective version

PDF iconAdopted guideline

Reference number EMEA/CHMP/167068/2004
Published 01/11/2005
Effective from 01/05/2006
Keywords Pharmaceutical development, quality, quality by design, enhanced approach, design space, proven acceptable ranges, process analytical technology, risk assessment, control strategy
Description This document describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.


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