Spain, Denmark, and U.K. build fast lanes for FIH trials — Back to School 2026

While Europe is pursuing broader clinical trial reforms through the proposed European Biotech Act, individual countries have launched fast-track review pathways for first-in-human trials with globally competitive timelines. Their goal is to attract more early-stage studies, giving patients earlier access to innovative therapies and increasing the likelihood that sponsors will return to the same countries for Phase II and later trials.

Three countries stood out in BioCentury’s conversations with European stakeholders for the speed of their review processes and their efforts to attract early clinical studies: Denmark, Spain, and the U.K. Belgium is also gaining recognition for its expedited review process...