OBJECTIVES: Hungary's accession to the European Union in May 2004 compelled reconsideration of the social insurance inclusion of pharmaceutical products. The Office of Health Technology Assessment (HTA) of the National Institute for Strategic Health Research was formed in 2004 with the aim of establishing an independent institution to support decision-makers in their rational use of healthcare resources. METHODS: The Office provides an organisational framework for the technology assessment that forms the basis for the medicine subsidy approval policy of the National Health Insurance Fund, and performs the related medical and economic assessment duties. The National Health Insurance Fund makes decisions regarding the granting of subsidies for medicines, based on the findings presented by the Office of HTA, which X determines the professional guidelines for analysing health technology, coordinates the assessment of new and existing technologies, and issues instructions for the use of individual technologies X provides reliable and undistorted information for the appraisal of individual procedures, comparing them with alternative opportunities for the use of resources based on a combination of clinical evidence, efficacy and cost-effectiveness factors, X facilitates the appropriate use of cost-effective healthcare technologies, and provides support for decision-makers. RESULTS: The majority of applications were related to anti-tumour drugs and products designed to treat diseases of the cardiovascular or central nervous system. The Office also performs problem-oriented comparative examinations, such as the comprehensive policy study of Positron Emission Tomography (PET) and Gamma-knife Surgery, Drug-eluting Coronary Stents, etc. CONCLUSION: In the initial period, staff at the Office of Health Technology Assessment focused primarily on assessments of medicines to determine their eligibility for social insurance funding, but as the new institutional structure becomes more firmly established, it is increasingly able to perform thorough, comprehensive assessments of other health technologies.