ICH M4Q - The Common Technical Document for the registration of pharmaceuticals for human use - Quality - Scientific guideline

This document provides guidance on the structure and format for presenting information on quality aspects in the Common Technical Document (CTD), covering Module 2.3 (Quality Overall Summary) and Module 3. It applies to all medicinal products for human use requiring a marketing authorisation. The applicant should consult applicable ICH and regional guidelines to determine the scientific data requirements for their specific product.

ICH M4Q(R2) represents a major revision of the guideline, to further improve registration and lifecycle management efficiency, facilitate digitalisation and to ensure compatibility with recent ICH guidelines as well as complex/novel product types and technologies.

Keywords: Common technical document (CTD), quality

Current effective version

ICH M4Q(R2) : Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality - Step 2b

Draft: consultation openConsultation dates: 25/06/2025 to 24/10/2025Reference Number: EMA/CHMP/ICH/178042/2025

ICH M4Q: Location issues for common technical document for the registration of pharmaceuticals for human use - Quality - questions and answers - Step 5

AdoptedReference Number: CPMP/ICH/4680/02Legal effective date: 01/08/2003

ICH M4Q: Common technical document for the registration of pharmaceuticals for human use - Quality - Step 5

AdoptedReference Number: CPMP/ICH/2887/99Legal effective date: 01/07/2003