Study Conducting - Regulatory Requirements
Information on Finnish regulatory process and requirements regarding the clinical trials on medicinal products, registry studies and medical device are found in Implementation -page.
Medical research involving human subjects is well regulated. The Finnish Medical Research Act 488/1999, amended 794/2010 (unofficial trasnslation) applies to all medical research in human subjects involving invasive procedures (e.g. diagnostic and therapeutic studies, and clinical intervention studies of medicines, medical devices, functional food, or biomaterials).
Finnish Medicine Agency, Fimea is national competent authority for regulating pharmaceuticals. Fimea must be notified of investigational clinical trials on medicinal products. Regarding the Medical Decvice, the main competent Authority is National Supervisory Authority of Health and Welfare, Valvira. The Pre-Notification for ethical evaluation is submitted to the National Committee on Medical Research Ethics, TUKIJA. The ethical admissibility of the clinical trial will be evaluated by TUKIJA or by one of the Regional Ethics Committees.