What is a Rare disease?
Rare diseases, also known as orphan diseases, are conditions that affect a small percentage of the population. The definition of what constitutes a rare disease varies by region.
Rare Diseases are defined in different parts of the world
United States
In the USA, a disease is considered rare if it affects fewer than 200,000 people. This definition is established under the Orphan Drug Act of 1983, which was designed to encourage the development of treatments for rare diseases.
Europe
In Europe, a disease is classified as rare if it affects fewer than 1 in 2,000 people. This is equivalent to fewer than 50 in every 100,000 people, as outlined by the European Medicines Agency (EMA).
China
In China, a disease is considered rare if it has an incidence of less than 1 in 10,000 among newborns. This definition highlights the prevalence of the disease within a specific population segment at birth.
Japan
In Japan, a rare disease is defined as one that affects fewer than
50,000 people. This threshold is used to identify diseases that need special attention due to their rarity.
Australia
In Australia, a disease is considered rare if it affects fewer than, or equal to, 5 in 10,000 people. This definition aligns with the criteria used in other regions to identify conditions that are uncommon in the general population.