Informed consent before a subject joins a clinical trial was always required in Swedish law until 2022. This study investigates if clinical trials in emergency situations were approved by the Swedish Medical Products Agency during 2004-2021. Among the 127 applications identified, a more detailed analysis was done for those received 2015-2021. Cardiovascular and central nervous system diseases were the most frequent conditions followed by sepsis and infections. Common trial characteristics were adult subjects only and Phase II/Phase III trials also performed in other EU Member States. Around one third of the emergency situation applications were rejected or withdrawn by the sponsor, in a few cases after approval since no participants could be recruited. Approved trial applications either included patients with chronic diseases consenting to the trial before the medical emergency situation or minors with both caregivers consenting as legally designated representatives. In a few applications an initial oral consent was accepted. Since 2022, a new clinical trials regulation applies in EU making it possible for emergency situation subjects to participate in clinical trials if there are scientific grounds for a direct clinically relevant benefit. However, the problem to acutely assign a legal representative for subjects without decision-making capacity remains.