ICH M4Q Guideline Updated

The draft of the updated guideline of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) entitled 'THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY M4Q(R2)' was published in May 2025 and is now available for public comment.

This new version focuses on revising the quality-related information in Module 2 and Module 3 of the CTD to cover all necessary quality-related information for the authorisation and lifecycle management of medicinal products for human use. It will apply to both APIs and finished medicinal products (chemical and biological), and is intended, among other things, to promote the efficiency and effectiveness of submissions and their assessment.

The table of contents includes the following chapters, with the chapters on Module 2 and Module 3 containing further subchapters and subitems. You can find an overview of the main chapters here:

SCOPE AND ORGANISATION
MODULE 2. COMMON TECHNICAL DOCUMENT SUMMARIES
2.3. Quality Overview
   2.3.1 General Information
   2.3.2 Overall Development and Overall Control Strategy
   2.3.3 Core Quality Information
   2.3.4 Development Summary and Justification
   2.3.5 Product Lifecycle Management
   2.3.6 Product Quality Benefit Risk (Optional)
MODULE 3. QUALITY
3.1 Table of Contents of Module 3
3.2 Body of Data
ABREVIATIONS
GLOSSARY
REFERENCES

The complete draft of the guideline 'THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY M4Q(R2)' as well as the business plan, concept paper and work plan can be found on the ICH website under the 'Public Consultations' tab.