Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - First version

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Document details

Download document Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - First version
Reference number EMA/CHMP/ICH/804273/2017
Status draft: consultation open
First published 2017-12-18
Last updated 2017-12-18
Consultation start date 2017-12-18
Consultation end date 2018-12-18
Email address for submissions ich@ema.europa.eu

Summary

This new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. The guideline strives to promote, for regulators (assessors and inspectors), an improved understanding of the Applicants’ pharmaceutical quality systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 guidelines.