Kim Huynh-Ba, MS, PMP, FAAPS
Managing Director, Pharmalytik LLC, Newark DE
Abstract
The 2025 revision of the ICH Q1 guideline represents a significant advancement in global stability testing expectations. By consolidating the existing Q1A–Q1F and Q5C guidelines, the revision introduces a unified framework that emphasizes risk-based decision-making, lifecycle management, and enhanced clarity for advanced therapy medicinal products (ATMPs). While the expanded content improves regulatory alignment and scientific robustness, the overall length and complexity of the guideline may present implementation challenges. Stakeholder engagement during the public comment period is essential to ensure the final version is practical, clear, and globally applicable.