Starting January 1st, 2026, PSURs will become mandatory for many active substances, making it essential for Marketing Authorisation Holders to be well-prepared. To ensure proper planning for the submission of these mandatory PSURs, it’s important to anticipate regulatory requirements and timelines well in advance.
Have questions about your specific regulatory case?
Our interactive planner helps you anticipate your upcoming obligations with confidence.
With just a few clicks, you can:
- Cross-reference data from the EMA EURD List and Article 57
- Generate a personalized calendar of deadlines in seconds
- Search by Active Substance or Marketing Authorisation Holder (MAH)
- Use partial terms for flexible and quick lookups
Check our PSURs smart tool here: PSURs Asphalion tool
Please note: While a standard PSUR may not always be required (e.g., for generic products), other pharmacovigilance and regulatory reporting obligations may still apply. We strongly recommend an expert review to ensure full compliance.
Disclaimer: The information provided is based on EMA’s EURD list and is for informational purposes only. The MAH remains legally responsible for verifying obligations directly with the competent authorities.
If you are a Marketing Authorisation Holder (MAH) in the European Union and need guidance on PSUR requirements or other pharmacovigilance duties, our Asphalion experts are ready to support you. Contact us: [email protected]
