ICH Q8 (R2) Pharmaceutical development - Scientific guideline
Table of contents
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.
Keywords: Pharmaceutical development, quality, quality by design, enhanced approach, design space, proven acceptable ranges, process analytical technology, risk assessment, control strategy
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations (ICH) guideline Q8 (R2) on pharmaceutical development - Step 5 (PDF/593.48 KB)Adopted
First published: 01/06/2009
Last updated: 28/05/2014
Legal effective date: 01/05/2006