Orphan diseases are typically those that are having no commercial incentives to research and develop actual therapies. More than 25 years of orphan drug regulations have yielded several new treatments for patients with rare diseases. To boost the pharmaceutical companies to invest in the development of orphan drug, various countries, beginning with the USA, they have announced their own regulations to provide suitable motivations. There is a significant degree of similarity in the incentives provided from one nation to another and this variety from market exclusivity for the product in its proposed indication (the most important incentive) to tax credits and reduction or waivers of fees. In this article it introduces the orphan drugs and gives legal framework for its regulation in US and Japan. Along with specifications for the orphan drugs it includes its requirements and features of Fast-track Approval process for quick Marketing authorization.
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