1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Sweden in relation to Decentralized Clinical Trials (“DCTs”). It supplements the regulations applicable to the EU and EEA described in the European Medicines Agency (“EMA”) guidebook. The provisions of the Clinical Trials Regulation (EU) No 536/2014 (“EU CTR”), which came into effect in January 2022, may be referred to where national legislation does not specifically address issues.

This guidebook focuses on the procedure to be followed for new clinical trial applications submitted from January 2023 in accordance with the EU CTR, supplemented by Swedish laws and regulations, where these are in existence.

The Swedish Medical Products Agency/Lakemedelsverket (“MPA”) was one of the first regulatory authorities in the European Union (EU) to start exploring decentralized clinical trials whereby, at the end of 2020, they conducted a feasibility study on DCTs with the aim to establish the conditions for how clinical drug trials can be conducted in a decentralized manner in Sweden.