Clinical trials of a medicinal product are conducted to gain knowledge about how the medicinal product works, what side effects it may have, and how it metabolized in the body. Such trials contribute to increased understanding of the types of treatments that can be provided and which treatment is the most effective, thereby offering significant societal benefits.
Clinical trials are subject to strict regulatory requirements. Regulation (EU) No. 536/2014 provides a unified European regulation for clinical trials of medicinal products for humans. This regulation has been implemented into Norwegian law through the Medicinal Products Regulation (FOR-2009-12-18-1839), ensuring that the rules governing clinical trials in Norway align with those applicable in the EU.
The EU regulation replaces the previous EU Directive 2001/20/EC, which was implemented in Norwegian law by Regulation No. 1321 of 30 October 2009 on clinical trials of medicinal products for humans. Both regulatory frameworks will apply during a transition period of three years until 30 January 2025. The new regulatory framework for clinical trials aims to make Europe more attractive for clinical studies and to ensure faster innovation through a simplified application process.
Approval and reporting requirements for clinical trials
If a study falls within the definition of a clinical trial that requires an application under the legislation, the party responsible for the study (the sponsor) must seek approval before the study can be conducted. The application for approval is submitted via the common European application portal, CTIS (Clinical Trials Information System). Whether the application is approved depends on an assessment of the safety of the participants in the trial and whether the trial is ethically and scientifically justified. The Norwegian Medical Products Agency (NOMA) and the Regional Committees for Medical and Health Research Ethics (REK KULMU) are responsible for making this assessment and issuing the final decision. During the transition period until 30 January 2025, applicants can choose whether to apply under the "old" or "new" framework.
In addition to requiring approval before the trial begins, there are also reporting requirements both during the study and upon its completion. While the study is ongoing, the sponsor is obligated to report to the NOMA about adverse events and serious deviations within specified deadlines, as well as to submit an annual safety report. Upon completion of the study, the sponsor must notify the regulatory authorities within 15 days and submit a final report within one year after the study concludes.
Decline in clinical trials
The number of clinical trials has decreased over the past 10 years in Norway. According to the NOMA's annual report for 2023, 98 applications for medicinal product studies were submitted in 2023, a decline from previous years, despite the introduction of new regulations and a new European application portal intended to stimulate more studies. The NOMA hopes that the decline is temporary and can be attributed to practical challenges related to the transition to the new regulations.
Relevant regulations and guidelines for clinical trials of medicinal products for humans are available here.
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