Rui Santos Ivo Advocates for Regulatory Frameworks Innovation at RAPS Euro Convergence 2026

Rui Santos Ivo, President of the INFARMED Board of Directors and Chair of the European Medicines Agency (EMA) Management Board, emphasized the need for regulatory frameworks innovation during the opening session of the Regulatory Affairs Professionals Society (RAPS) Euro Convergence 2026 conference held in Lisbon. He described how regulatory activities have evolved beyond compliance and submission processes to become deeply integrated across the full lifecycle of medicines and medical devices. This shift positions regulation as a scientific and strategic function central to innovation decisions, development pathways, market access, product safety, and public confidence, with these changes being particularly evident across Europe.

Lifecycle Approach to Oversight

The most impactful elements of Ivo’s remarks center on the transformation of regulatory work into a lifecycle-spanning activity that directly influences innovation and patient access. He noted that regulators must now operate with greater scientific depth and strategic insight, moving away from purely procedural tasks toward active participation in development, safety monitoring, and evidence generation. Specific challenges highlighted include advanced therapy medicinal products (ATMPs), digital health technologies, and artificial intelligence applications, where regulatory systems must balance rigorous safety standards with the capacity to adapt quickly. These observations draw directly from the practical realities discussed at the conference, which features dedicated tracks on MedTech, pharmaceuticals, biotech, and digital health to address such complexities.

European Strategy Foundations

The conference program and Ivo’s intervention rest on the established European approach of maintaining a stable, predictable, and evidence-based regulatory environment, as reaffirmed in recent European Commission life-sciences strategies. This foundation incorporates the new EU Pharmaceutical Legislation and the Biotech Act, alongside proposed reforms to the Medical Device Regulation (MDR). Pre-conference workshops and sessions on regulatory capabilities provide the practical methodology for translating these legislative developments into operational practice, emphasizing coordination among member states and effective implementation mechanisms. Such structured dialogue supports the claims that Europe can remain competitive while upholding high standards for safety and quality.

Impacts on Access and Assessment

A regulatory system that integrates scientific evaluation throughout the product lifecycle can accelerate evidence generation suitable for health technology assessment (HTA) bodies, potentially shortening the interval between authorization and reimbursement decisions. By fostering innovation in ATMPs and digital health while preserving public trust, these approaches may improve predictability for manufacturers and payers alike. The RAPS Euro Convergence 2026 platform, with its focus on real-world regulatory challenges, illustrates how cross-stakeholder collaboration can strengthen the interface between regulatory approval and downstream economic evaluations, supporting more efficient resource allocation in European healthcare systems.