Clinical drug trials on humans are systematic studies of a drug with the purpose of gaining knowledge or confirming knowledge of efficacy, interactions, side effects, pharmacokinetics or investigating therapeutic value.

The Icelandic Medicines Agency (IMA) and the national bioethics committee (VSN) review the quality of the study and the study drug as well as to ensure the safety of the participants in the clinical pharmaceutical study.

The trans-European portal - CTIS

On January 31, 2022, a new regulation on clinical drug trials conducted in countries in the European Economic Area entered into force. Thereby, the submission, evaluation and monitoring process has been coordinated in a special portal, the Pan-European portal for clinical drug trials (e. Clinical Trials Information System - CTIS)

CTIS is a foundation where the clinical trial process is followed from start to finish. The portal ensures transparency and overview and acts as a monitoring tool.

As of January 31, 2022, authorisation for clinical trials of a medicinal product can only be applied for through CTIS.

CTIS includes areas for sponsors of clinical trials and their organizations, areas for EEA Member States, the European Commission, and the official website. Security is ensured at all these sites.

• Applications for clinical trials and appropriate documents can be submitted at the sponsors' work area.

• Clinical trials are monitored and evaluated at the work sites of the EEA Member States and the European Commission.

• The public can access detailed information on all clinical trials conducted in the EEA region from the time the data is submitted until it is processed in the CTIS on the official CTIS website.

The CTIS is evaluated and supervised by the EEA Member States and maintained by the European Medicines Agency (EMA). The CTIS is monitored by the European Commission for compliance with the Regulation.