We had the pleasure of attending DIA Europe 2025 in Basel this March, where leaders from regulatory agencies, industry, and academia gathered to explore the evolving landscape of healthcare regulation and evidence generation. Three sessions stood out for us, each highlighting crucial shifts in how regulators are leveraging real-world evidence (RWE) and digital tools to shape the future of medicines development and safety monitoring.

1. Real-World Data (RWD) Perspective from BfArM

There was a heavy focus on real world evidence (RWE) at DIA Europe. The presentation by BfArM highlighted what they are doing in this area.

The Health Data Lab (HDL) at the BfArM leverages claims data, electronic health records, prescription data, inpatient/outpatient data, and registries. The BfArM research division uses primary and secondary data to inform regulatory decisions, including pharmacogenomic research and have pilots underway linking cancer registries with other data sources to create a more complete picture of patient journeys.

The presenter stated that one of the key principles is ensuring methodologically sound decisions through secure environments and a central access body for health data. As always, it’s important that real-world studies are conducted under controlled, GDPR-compliant conditions and steps are being taken towards the European Health Data Space (EHDS) regarding this.

This session reaffirmed Germany’s leadership in building a national infrastructure that supports evidence-based regulation with an emphasis on data quality, secure processing, and transparency.

Key Takeaways:

• Germany is creating a sophisticated, secure, and standardised ecosystem for RWD that can inform regulatory decisions.
• BfArM is focused on methodological rigour, enabling deeper integration of RWE across the product lifecycle.
• The move towards a more connected EHDS is well underway.

2. MHRA Townhall

This was an interesting session showcasing strategic areas for the MHRA as they look to the future.

• Clinical Trials Modernisation: From September 2023, the MHRA consistently met its 98% performance target for statutory timelines. A notification scheme is in place for lowest-risk trials, with some being approved within 14 days, earlier than the statutory 30 days. Combined ethics/regulatory reviews for Clinical Trials of Investigational
  Medicinal Products (CTIMPs) continue to improve speed and efficiency.
• New Clinical Trial Regulations: New legislation was laid in December 2024 with implementation set for early 2026 after a 12-month transition once legislation is passed. Emphasis was on safety, innovation, and global competitiveness.
• Innovative Licensing and Access Pathway (ILAP): Relaunched in January 2025, ILAP provides a streamlined, pre-market access pathway for transformative medicines with early engagement across the NHS, HTAs, and MHRA.
• AI and Data Strategy: The MHRA is leveraging AI in areas like GMP automation, literature monitoring, risk prioritisation, and illicit website detection. The Airlock Programme provides a regulatory sandbox for AI.
• Real-World Evidence Strategy: A new RWE Scientific Dialogue Programme, initially a one-year pilot, aims to support sponsors with regulatory expectations on RWE work collaboratively with NICE and industry sponsors to produce reflection papers helping integrate real-world data into submissions. This session demonstrated the MHRA’s commitment to innovation, resilience, and strategic use of technology and RWE to future-proof regulation.

Key Takeaways:

• The MHRA is actively transforming UK regulation to be more agile, patient-centred, and innovation-friendly.
• New frameworks like ILAP and the Airlock Programme offer collaborative spaces for early engagement and testing.
• RWE is increasingly important in supporting future regulatory decision-making, and the MHRA is building the guidance and infrastructure to support this.

3. A New Approach to Spontaneous Reports to Strengthen Real-World Evidence

This session provided an insight into how spontaneous data from the yellow card system could potentially be used to bolster some additional PV requirements.

• Yellow Card Vaccine Monitor: Introduced during COVID-19, it featured dynamic, conditional logic-based questionnaires, automated follow-ups, and high engagement (70% response rate).
• Impact: Enabled real-world safety data collection in special populations such as pregnant women and supported long-term outcome monitoring.
• Spontaneous to Structured: The strategy demonstrated how a system used for spontaneous reports was adapted to support active follow up and active surveillance.
• Future Vision: Plans include expanding system-generated follow-ups for both established and novel products and integration with statistical software and embedding these tools into the MHRA’s signal detection infrastructure.

This innovative work positions spontaneous reporting not just as a safety net, but as a potential contributor to high-quality RWE.

Key Takeaways:

• The Yellow Card system is evolving into a more proactive, structured, and data-rich platform for pharmacovigilance.
• Automation and conditional logic in follow-up improves data quality and patient engagement.
• There is strong potential for spontaneous reports to become a significant component of real-world evidence strategies.

Conclusion

From national health data initiatives to reimagined pharmacovigilance systems and AI integration, these sessions offered a glimpse into the regulatory environment of tomorrow. At Sagittal Pharma Consulting, we see these developments as highly aligned with our own mission – to help clients navigate the future of evidence generation and regulatory engagement with clarity, agility, and confidence.

If you’d like to explore how Sagittal can support your regulatory or PV strategy, feel free to get in touch.