Orphan Drug Designation (ODD)
Orphan Medicinal Product is a medicinal product intended for diagnosis,
prevention or treatment of life - threatening or chronically debilitating
condition (s) affecting not more than 50,000 patients in Japan.
PAL
Article 2 (Definitions)
Paragraph 14. The term "orphan drug" used in this law refers to drugs specified pursuant to the provisions of Article 77-2, Paragraph 1, and the term "orphan medical device" used in this law refers to medicinal products specified pursuant to the provisions of the same paragraph.
