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