07/12/26

The EU’s new pharmaceutical legislation is the most significant reform of the medicines regulatory framework in over two decades. It marks a decisive step towards a modern, agile and future-ready system for how medicines are developed, authorised and delivered to patients across Europe.

This reform is central to strengthening Europe’s pharmaceutical sector, driving innovation, boosting investment and reinforcing global competitiveness, while upholding the highest standards of safety, efficacy and quality. It is also about ensuring that patients across the EU have faster, more equitable and reliable access to the medicines they need.

The new framework will help build a pharmaceutical ecosystem that is more responsive, more competitive and better equipped to meet public health needs. In particular, it will:

Place the EU at the forefront of pharmaceutical innovation. Through targeted incentives and new regulatory tools such as regulatory sandboxes for breakthrough medicines, adapted frameworks for certain novel treatments, decentralised manufacturing, platform marketing authorisations, facilitated use of real-world evidence and health data and integration of AI along the medicines lifecycle.
Speed up the path from innovation to patient access, by reducing administrative burden, shortening evaluation timelines for new medicines and reforming the European Medicines Agency, while the EU’s robust, science-based assessment process will continue to underpin all medicine authorisations.
Support faster market entry of generic and biosimilar medicines, through great legal clarity and simplification including the application of the Bolar exemption.
Strengthen Europe’s resilience against shortages with a reinforced EU framework for monitoring, prevention and coordination, stronger obligations for companies, and a focus on critical medicines and supply vulnerabilities.

The conference will explore how the new EU pharmaceutical legislation can be translated in real-word impact through its implementation.

Sessions will cover new regulatory tools for innovative medicines; digital and AI-enabled regulation for medicines; incentives for innovation including for areas of unmet medical needs, orphan and paediatric medicines, repurposing; measures to improve timely access to innovative, generic and biosimilar medicines; actions against antimicrobial resistance; and stronger prevention of shortages and security of supply.

Bringing together policymakers, regulators, researchers, industry, healthcare professionals and patient organisations, the conference will provide a high-level forum to shape the successful implementation of the EU’s new pharmaceutical legislation.

Physical attendance is by invitation; however, the plenary sessions and panel discussions will be livestreamed for all interested parties.

by Dina Diek