New ICH Q1 Draft Guideline on Stability Testing

On 11 April 2025, the revised draft of ICH Q1, “Stability Testing of Drug Substances and Drug Products,” reached Step 2b of the ICH process. Shortly afterward, the EMA released the document for public consultation, with feedback accepted until 30 July 2025. This new guideline consolidates and updates previous Q1A–F and Q5C documents, broadening its scope to cover synthetic and biological drug substances and products, including vaccines, gene therapies, and combination products. It aligns with ICH Q12 on lifecycle stability management and includes all climatic zones for global harmonization. Key additions involve stability guidance for ATMPs and emphasize Quality by Design and risk-based approaches (ICH Q8–Q11, Q14).

To support industry understanding, the ECA is offering a Live Online Training on 18 June 2025, led by Dr. Joachim Ermer. The session will explore regulatory expectations, data analysis, and implementation strategies, while offering practical insights into managing stability across a product’s lifecycle.

18-05-2025