As the 24th RA Conference by Medicines for Europe in Amsterdam comes to a close, our colleagues Lidia Cánovas and Laura Casals share some key highlights from the discussions.
The main concepts of the new pharmaceutical legislation package were explored in depth, giving much clearer visibility on how the new processes are expected to unfold. Among the most relevant topics discussed:
- ePI implementation and digital product information rollout
• ASMF single assessment procedure
• Changes to data and market protection periods
• Market accessibility measures
• Environmental Risk Assessment (ERA) requirements
• Management of shortages, including Shortage Prevention Plans (SPP) and vulnerability assessments
Regulators strongly emphasised the need to reinforce Post-Marketing Surveillance (PMS) systems and enrich regulatory data, underlining that future decision-making will increasingly rely on structured, high-quality datasets.
Ms. Marta Marcelino, Chairperson of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), described the CMDh future as “Digital by default”, aiming for data-driven and automated processes, AI-enabled support, and interoperable systems across Member States.
María Jesús Lamas, Director of Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), highlighted that the new pharmaceutical legislation is expected to strengthen the EU generic medicines industry and described it as a highly positive and well-received package of measures.
From our team’s perspective, three major trends stood out:
🔹 A clear acceleration toward digitalisation and structured data across regulatory procedures
🔹 Increased expectations around proactive shortage prevention and supply chain resilience
🔹 Greater regulatory convergence and harmonisation, with automation and AI playing a supporting role
The direction is clear: compliance will increasingly mean being digitally prepared, data-ready, and strategically aligned with evolving EU processes.
If you would like to explore how these upcoming changes may impact your regulatory roadmap, feel free to reach out. We are here to help! [email protected]
