What are the requirements to start
clinical trials in Poland?
Regulatory Agency/Competent Authority (RA) and Ethics Committee (EC) approval is required prior to any new drug or non-CE marked medical device clinical trial initiation in Poland.
The Clinical Trial Application (CTA) should be submitted to the RA by the clinical trial sponsor or its authorized representative. Before the CTA is filed to the RA and EC, all non-EU sponsors must appoint a so-called ‘Legal Representative’ that has to be legally established in the European Union.
Application for drug studies can be made to RA and EC in parallel, however, the CTA for medical devices must be made to the RA after EC approval has been obtained.
The application form, cover letter, protocol synopsis and all documents distributed to patients, including Informed Consent Form, must be submitted in Polish. For medical device studies RA requires the full protocol translation into Polish as well. The protocol, investigator’s brochure, CRF and all other study documents may be submitted in English, however, RA requires that some of them are submitted with its certified translation into Polish e.g. Certificate of Good Standing.
RA requires that the contracts for all participating sites in Poland must be signed and submitted to RA before the CTA submission (medical device studies) or between the CTA submission and the end of 60-day period of CTA approval process (drug studies). The original-signature or notarized copies of the signed contracts must be submitted to the RA. The contract with a public institution must be in Polish. The contract with a private institution and principal investigators may be in English. To expedite the process in large studies, the initial request may be made for a reduced number of sites. Following the initial RA approval and when the site-specific documents, including signed contracts for the remaining sites, are ready for submission, the request may be amended to add these clinical sites. The review and approval of additional sites by the RA can take up to 35 days.
If study drug or the medical device will be imported from a non-EU country, then an import license is required from the RA. The quantity of the study drug or medical device to be used in the study must be specified – as per standard practice a surplus of 25 % may be included in the request to ensure the sufficient number of study supplies are imported to Poland.
From all Principal Investigators participating in the study in Poland a Country Coordinator must be chosen and his/her local EC becomes the Central EC (CEC) responsible for review and approval of the whole study. The CEC issues the single opinion on the clinical trial 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 on the investigator and the site facilities. If the local ECs will give favorable opinions about the sites or will not respond during the mentioned above timelines, the study is considered approved for all sites submitted within the application.
Reports are made to the RA and CEC by the sponsor or its representative e.g. by responsible clinical research associate (CRA) or PVG associate.
IMP Clinical Trials
Serious Adverse Events that result in death or are life-threatening must be reported to the CEC and RA as soon as possible but no later than within 7 days after site notification. After the initial SAE report a follow up should be made within next 8 days. Suspected Unexpected Serious Adverse Reactions must be reported to CEC and RA within 15 days unless the SUSAR results in death or is a life-threatening situation and in this case the CEC and RA must be notified as soon as possible but no later than within 7 days after site notification. All non-SUSAR Adverse Drug Reactions are reported to the CEC and RA in an annual study report.
Medical Device Clinical Trials
All SAEs that occurred in Poland, whether or not the Serious Adverse Event is related to the medical device, must be reported to the CEC and RA as soon as possible but no later than within 7 days after site notification.