Orphan drugs are drugs not widely developed by the pharmaceutical industry for financial reasons, as they are intended for a small group of patients and yet respond to public health needs.
The United States was the first country to develop a law, the Orphan Drug Act in 1983, allowing orphan status to allow subsidies for the development of these products, as well as other support measures, until its commercial approval. The European Union initiated a common policy in this area in 1999.
According to the European Union, an orphan medicinal product is one that meets the requirements:
Criteria for a drug to be classified as an orphan drugwiki
