Clinical Trials

Guidance on clinical trials may include discussions on which studies require an application, how to apply for clinical trials, what is required to obtain approval, and documentation requirements. Questions regarding hospital exemptions for advanced therapies may also be addressed.

Clinical research involving medicinal products (or substances intended for use as a medicinal product) and medical devices that are not CE-marked or are used outside their intended purpose generally requires submission of an application to the Norwegian Medical Products Agency (NOMA).

This applies both to authorised medical products and those under development, including advanced therapy medicinal products (gene therapy, cell therapy, and tissue therapy).

Approval of a clinical trial is based on an assessment of the documentation submitted by the applicant.