The Guideline “on stability testing for applications for variations to a marketing authorisation” has been updated to Revision 3, introducing important clarifications for companies managing post-authorisation changes.
This Guideline provides comprehensive guidance on the stability data that must be generated and submitted to support a variation to a marketing authorisation. It applies across different variation categories and aims to ensure consistent regulatory expectations throughout the product lifecycle.
In particular, Revision 3:
- Defines stability testing requirements for Type IA and Type IB variations
- Clarifies the data requirements for commonly submitted Type II variations
- Promotes a harmonised and risk-based approach to stability studies when implementing changes
Date of application: 15 January 2026
Access the full Guideline here:
https://bit.ly/4jbX9kL
How ASPHALION can support you
ASPHALION’s regulatory experts can help you assess the impact of this updated Guideline on your current and planned variations, define appropriate stability strategies, and prepare robust variation dossiers in line with the latest regulatory expectations. Our team supports you throughout the full lifecycle of your products, ensuring compliance while optimising timelines and resources.
If you have questions about how Revision 3 may affect your portfolio, our experts are ready to support you. Contact us at: [email protected]
