Regulatory Strategies For Orphan Medicine and Vaccine Development On A Global Scale
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Copyright: © 2020 . This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
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.
