Establishing the role of M4Q(R2) as the main source of the structure and location of regulatory quality information. Organizing product and manufacturing information in a suitable format for easy access, analysis, and knowledge management.

To avoid generating and compiling different registration dossiers, this guidance describes a format for the Quality section of the CTD that will be acceptable in all three regions.

This document provides detailed guidance on the quality information to be included in module 2 and module 3 of the common technical document. Keywords: Common technical document (CTD), quality. ICH: M 4 Q: Common technical document for the registration of pharmaceuticals for human use - Quality - Step 5.

In order to facilitate the implementation of the M4Q guideline, the ICH Experts have developed a series of Q&As which can be downloaded from the ICH web site: http://www.ich.org M4Q Questions & Answers History

description of the desired product and product-related substances and a summary of general properties, characteristic features and characterisation data (for example, primary and higher order structure and biological activity), as described in 3.2.S.3.1, should be included.

This document provides additional guidance for the preparation of an application file in the common technical document - quality section (CTD-Q) format. It addresses the relationship between linked CTD-Q sections for certain parameters, such as polymorphism, impurities or …

M4Q(R1) is now due for revision to further improve registration and lifecycle management efficiency, leverage digital technologies, and accelerate patient and consumer access to pharmaceuticals. The specific drivers for this revision include: 1. Several ICH regions have not fully implemented ICH M4Q(R1). The modernization

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of …

In November 2005, the ICH Steering Committee adopted a new codification system for ICH Guidelines. The purpose of this new codification is to ensure that the numbering / coding of ICH Guidelines is more logical, consistent and clearer.

In summary, M4Q(R2) should enable efficient, effective, patient-centric and globally harmonised submissions, assessment and life cycle management, and minimize dossier redundancies. M2 should provide a sufficiently comprehensive overview of the pharmaceutical product and its …