ASPHALION | Does your Molecule need a PSUR in 2026?

To support you, we’re launching a series of informative posts on PSURs, covering key concepts, regulatory expectations, and best practices. Plus, we’ll soon be introducing a powerful new tool designed to make PSUR preparation and management easier than ever. Stay tuned!

To support you, we’re launching a series of informative posts on PSURs, covering key concepts, regulatory expectations, and best practices. Plus, we’ll soon be introducing a powerful new tool designed to make PSUR preparation and management easier than ever. Stay tuned!
July 31, 2025

At Asphalion, we specialize in seamless end-to-end PSUR management. With our expert team and AI-powered technology, you can stay compliant without errors and on time. 

You can now plan your PSURs using our interactive planner to anticipate your 2026 obligations. Our smart tool cross-references public data from the EURD List and EMA’s Article 57, providing a personalized calendar of your deadlines in seconds! 

Starting January 1st, 2026, PSURs will become mandatory for a broad range of active substances. This change underscores the importance for Marketing Authorisation Holders to be thoroughly prepared. Anticipating regulatory requirements and timelines well in advance is crucial for successful planning and submission of these mandatory reports. 

Our user-friendly tool allows you to search by Active Substance or Marketing Authorization Holder (MAH), providing a comprehensive report that details which PSURs are required and which are not. This feature is designed to streamline your processes, saving you time and effort. 

Check out our new PSURs tool here: https://www.asphalion.com/psurs/  

Reach out today and outsource your PSUR management with confidence! For more information: [email protected] 

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