Regulatory Update: ICH Reviews CTD Guideline Step 2b – Quality
Consultation Period: June 2025 – October 2025
The ICH has released a Step 2b draft revision of the CTD guideline – Quality, marking a significant step toward the global harmonization and digitalization of quality documentation for medicinal products.
What’s changing?
The revised guideline provides a structured and granular approach to presenting quality information for both initial marketing authorization applications and post-approval submissions.
Key proposed changes include:
Revamped Module 2.3
Now designed to serve as the core document for quality assessment, it will include:
2.3.1 General Information
2.3.2 Overall Development and Control Strategy
2.3.3 Core Quality Information
2.3.4 Development Summaries and Justifications
2.3.5 Product Lifecycle Management Information (if applicable)
2.3.6 Product Quality Benefit-Risk Considerations (if applicable)
Module 3 as a Supporting Repository
Detailed methods, data, and supportive information will be housed in Module 3 to back up the streamlined Module 2.3.
This represents a paradigm shift in how we approach the quality section of regulatory dossiers – enabling easier access, better data analysis, and improved knowledge management. But are these truly changes for the better?
We encourage all stakeholders to review the draft and contribute to the consultation process.
Read more about the consultation on the European Commission’s website.