Tag: EMA stability testing

How to Align Your Protocol with Both FDA and EMA Stability Requirements

Pharmaceutical manufacturers aiming for both U.S. and European Union (EU) markets must align their stability study protocols with the requirements of both the FDA and EMA. While both regulatory agencies adopt ICH Q1A(R2) as a baseline, there are critical differences in expectations, documentation, and justification. This how-to guide walks you through the steps needed to…

Regional Guidelines: FDA, EMA, ASEAN, TGA, Regulatory Guidelines

Comparing FDA vs EMA Approaches to Stability Studies

When preparing a regulatory submission for global markets, pharmaceutical companies must navigate differing expectations from agencies like the USFDA and the European Medicines Agency (EMA). Although both follow ICH guidelines, the interpretation, implementation, and documentation of stability studies can vary. In this tutorial, we break down the core differences and actionable tips for compliance. 📝…

Regional Guidelines: FDA, EMA, ASEAN, TGA, Regulatory Guidelines