Icelandic Medicines Agency
Clinical trials
A clinical trial of a medicinal product is a systematic study of a medicinal product for the purpose of obtaining or confirming knowledge of its effects, interactions, adverse reactions or pharmacokinetics, or of investigating its therapeutic value.
The Icelandic Medicines Agency and the National Bioethics Committee review the quality of the trial and the investigational medicinal product, as well as ensuring the safety of participants in the clinical trial of a medicinal product. Fees are charged in accordance with the Icelandic Medicines Agency’s fee schedule. An invoice is sent after the application has been received.
Clinical Trials Information System (CTIS)
On 31 January 2022, a new regulation on clinical trials of medicinal products conducted in the countries of the European Economic Area entered into force. As a result, the submission, assessment and supervision process has been harmonised in a dedicated portal, the Clinical Trials Information System (CTIS).
CTIS is a platform where the clinical trial process is followed from start to finish. The portal ensures transparency and overview and serves as a tool for supervision.
On the public CTIS website, anyone can access detailed information on all clinical trials conducted in the EEA, from the time the data has been submitted until it has been processed in the CTIS system.
Information on clinical trials of medicinal products in the European Economic Area from 31 January 2022 can be searched for on the website of the European Medicines Agency. An interactive map of clinical trials in Europe is also available there.
Authorisation for clinical trials can only be applied for in CTIS
CTIS includes domains for sponsors of clinical trials and their organisations, areas for EEA Member States, the European Commission and a public website. Security is ensured in all these domains.
Applications for clinical trials and the relevant documents can be submitted in the sponsor workspace.
Clinical trials are monitored and assessed in the workspace for EEA Member States and the European Commission.
EEA Member States assess and supervise clinical trials in CTIS, while the European Medicines Agency (EMA) manages and maintains the system. The European Commission is responsible for ensuring that CTIS complies with the Regulation.