Attention Marketing Authorization Holders (MAHs)!
A major transformation is reshaping the regulatory landscape for medicinal product data in Europe.
The Network Data Steering Group (NDSG) — composed of European medicines agencies — has released pivotal recommendations to enhance the management of master data for medicinal products. This initiative lays the foundation for a centralized EU product data repository, advancing streamlined regulatory processes, higher data quality, and a more agile oversight.
What You Need to Know about the initiative:
- It supports EMA’s 2028 Vision: Driving data-driven decision-making and enabling smart, digital-first regulation across EU.
Key highlights:
- Stepwise Implementation: Gradual rollout using international standards such as ISO IDMP/FHIR.
- Enhanced Data Quality: Robust validation processes to ensure consistency and usability.
- Collaboration & Interoperability: Coordination among regulators and stakeholders, adopting international standards to facilitate interoperability.
Why It Matters:
This initiative marks a critical shift towards a centralized, standardized, and digital regulation frameworks across the EU.
Need to stay ahead of the curve?
Asphalion is here to help you interpret, prepare for, and implement these changes — ensuring your product data remains compliant, future-ready, and aligned with the latest EMA vision.
Contact us! [email protected]
