Legislations, Regulations and Policies for Orphan Drugs by Country.

HTA, Health Technology Assessment; MOH, Ministry of Health; NHIF, National Health Insurance Fund; FDA, Federal Drug Administration; IQWiG, Institute for Quality and Efficiency in Health CareN.B. Countries included within the EU have access to an overall range of incentives offered in over-arching EU legislation for medicines that have been granted an orphan designation by the European Commission including: fees reduction for protocol assistance, marketing authorization application (and the potential for accelerated applications), inspections, annual fees and products utilising the centralised procedure as well as access to free scientific advice regarding marketing authorization and clinical trials.Cost-effectiveness HTA criteria in decision making includes the importance of clinical efficacy.Legislations, Regulations and Policies for Orphan Drugs by Country.