PORTUGAL Trends and Developments Contributed by: Patrícia Paias, Francisco Marques Azevedo and Clara Nolasco Lamas, MFA Legal & Tech
mentation timelines continue to evolve as the regime becomes applicable over 2026–2028.) Taken together, these EU and national initiatives are contributing to a broader regulatory evolution affect- ing the Portuguese life sciences sector. They reinforce policy priorities relating to supply security, equitable access to medicines, evidence based health technol- ogy assessment and the responsible adoption of digi- tal and AI driven healthcare technologies. Access to Innovation and Clinical Research Major multinational pharmaceutical companies con- tinue to invest in clinical research activities and new product launches in Portugal. Global firms have reaf- firmed their commitment to ongoing research and development activities and the introduction of new treatments, even amid broader cost pressures affect- ing the pharmaceutical industry. Portugal will host key scientific and investment events in 2026, including major life sciences investment and partnering conferences such as LSX Europe and associated Life Science Week initiatives. These events highlight growing international engagement with local biotech, diagnostics and digital health innovators. In 2026, Law No 9/2026 entered into force, adapting the Portuguese legal framework to the requirements of Regulation (EU) No 536/2014 on clinical trials. This EU regulation replaces the old framework with a single, harmonised system for clinical trials across all Mem- ber States, aiming to simplify assessments, enhance patient safety and ensure consistency across Europe. Law No 9/2026 modernises the clinical trial process in Portugal, making it faster, more transparent and safer. Key changes include electronic submissions, real-time monitoring and streamlined procedures for multicentre and digital trials, designed to reduce administrative burdens and accelerate patient access to innovative therapies. These updates are expected to have a significant impact on Portugal’s clinical research landscape in 2026. Digital submissions and harmonised procedures facilitate faster trial approvals, particularly for complex or multicentre studies. Real-time monitoring enhanc-
es safety and regulatory oversight, enabling quicker intervention if issues arise and improving transparency between sponsors and authorities. Streamlined pro- cesses for digital and multicentre trials support greater participation by Portuguese research centres in inter- national studies, fostering collaboration, investment and access to cutting-edge therapies. Overall, these developments position Portugal as a more competitive and attractive location for clinical research and are expected to strengthen the national clinical trial ecosystem throughout 2026 and beyond. In addition, the implementation of Law No 71/2025, of 22 December 2025, continues to shape Portugal’s clinical research and medical device landscape. This law fully aligns national rules for clinical investigations and performance studies of medical devices and in vitro diagnostics (IVDs) with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), clarify- ing authorisation procedures, ethical oversight and participant protections. Alongside this, Infarmed has introduced streamlined procedures for multicentre and digital trials, including electronic submissions and real-time monitoring requirements, designed to reduce administrative burdens and accelerate patient access to innovative therapies (in January 2026, Por- tugal commenced participation in FAST EU – Facilitat- ing Accelerated Clinical Trials in the European Union). These developments are being implemented in par- allel with ongoing MDR/IVDR transition requirements and national updates under Decree Law No 118/2025, 13 November 2025, which harmonises procedural and safety standards for devices, including provisions on reprocessing and supply chain transparency. Together, these legal frameworks are expected to enhance regulatory predictability, strengthen over- sight of multicentre and complex trials and support the broader adoption of digital and innovative medi- cal technologies across Portugal’s healthcare system. Distribution and Supply Chain Priorities The distribution of pharmaceutical products remains a strategic focus within the Portuguese healthcare sys- tem. In 2026, industry stakeholders emphasised sev- eral emerging priorities designed to strengthen supply
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