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Device companies entering clinical trial phase in Europe face a quagmire regulatory environments in different EU countries. In the last 10 years Central and Eastern European countries, including Poland, Czech Republic and Hungary have moved to the forefront of both pharmaceutical and device enrollment due to many patients who are in need of receiving cutting edge therapies, ambitious and well trained physicians and transparent regulatory process.

Fortuna Clinical will assist each client in their submission and registration tasks, and will contract individual medical centers and operators.

REGULATORY PROCESS DURATION IN CENTRAL/EASTERN EUROPE
COUNTRY TIME TO PREPARE SUBMISSION WAITING TIME FOR ECS APPROVAL WAITING TIME FOR RA APPROVAL TOTAL
Bulgaria 25 days 30 days n/a 50 days
Latvia 25 days 30 days n/a 50 days
Poland 25 days 60 days n/a 80 days
Czech Republic 25 days 60 days n/a 80 days
Serbia 30 days 60 days 60 days 150 days
  • EU countries ‐ submission only to Local Ethics Committees
  • Serbia ‐ sequential submission to LECs and Regulatory Authority

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