Abstract
Rare diseases (RDs) are chronic, life-threatening medical conditions individually affecting a low percentage of the population compared to other diseases. A medication used for diagnosis, prevention, or treatment of a rare disease may be known as an Orphan Drug (OD). There is no universal definition for RDs or ODs. This systematic review (SR) identified the quantitative and qualitative criteria used to define RDs, and ODs as well as the underlying rationale, internationally.
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