Журнал молекулярной фармацевтики и исследований органических процессов

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Regulatory Strategies For Orphan Medicine and Vaccine Development On A Global Scale

Ranjini D.M.

Orphan drugs are medicines or vaccines intended to treat, prevent or diagnose a rare disease (viz., Huntington's disease, myoclonus disease, Tourette syndrome, etc.). The definition of rare diseases varies across jurisdictions but typically considers disease prevalence, severity, and existence of alternative therapeutic options. A rare disease is not universal and depends on the legislation and policies adopted by each region or country.