Poland is located in Central Europe, has population of 37.9 million people and is the fifth-most populous member state of the European Union. Poland remains to be one of the largest clinical trial markets in CEE, having a share close to 20% in terms of the number of clinical trials held.
An EU member since 2004, Poland has its medical and pharmaceutical legislation harmonized with the EU. The typical timeline for receiving authorization from the regulatory authorities to conduct medicinal or device trials is 60 days.
Similarly to other countries within the EU, Poland requires Regulatory Agency/Competent Authority (RA) and Ethics Committee (EC) approvals before the drug or device trial can start.
Regulatory Agency/Competent Authority (RA) approval
The Clinical Trial Application (CTA) should be submitted to the RA by the clinical trial sponsor or its representative. To apply for the trial approval in the EU, sponsor who do not have a registered office within the territory of the EEA has to assign EU legal representative to act as primary contact for the Authorities on behalf of the Sponsor.