1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape in Poland in relation to Decentralized Clinical Trials (DCT) with medicinal products. It supplements the regulations and guidance applicable to the EU and the EEA described in the European Medicines Agency (“EMA”) guidebook. 

In Poland, the EU’s Clinical Trial Regulation EU 536/2014 has been adopted at a national level through its Act of March 09, 2023, on Clinical Trials of Medicinal Products for Human Use (“Act 2023”), which entered into force on 14 April 2023.

Poland has in recent years allowed some elements of DCTs to take place, albeit in the absence of a legislative framework specifically permitting them.

Note that this guidebook is focused only on commercial clinical trials.