How long does it take to start a new
clinical trial in Poland?
A decision on a valid request for authorization of clinical trials involving general medicinal products or medical device trials will be given within 60 days of receipt. Usually within 1-2 weeks of the study drug CTA submission the RA sends a confirmation letter informing that the 60-day approval period has been started. After that time the applicant of the submission will usually be notified in writing of the acceptance or, if no correspondence documenting non-acceptance or acceptance subject to specified conditions is received, the trial can be considered authorised.
Where notification of grounds for non-acceptance is made, the sponsor will have 14 days in which to respond with an amended request for further consideration. The final decision will be given within 60 days of receipt of the original request.
Written authorization will be given concerning trials involving gene therapy, somatic cell therapy or xenogenic therapy within 60-90 days, however, that period of time may be extended for additional 90 days if an additional consultation is required.
The application for EC review must be made to the local EC (which becomes the CEC for the trial) depending on the location of the Country Coordinator. The CEC submission must be made no later than 2 weeks before the EC meeting. The CEC issues the single opinion on the study and directly informs about the study the local ECs of all participating Principal Investigators. The local EC then, within 2 weeks, is responsible for giving an opinion about the investigator and the site facilities. The CEC must give its written opinion within 60 days of receipt of a complete submission package, however, usually it takes only 1-2 weeks from the date of the EC meeting.