Abstract
A REVIEW ON REGULATORY ASPECT OF ORPHAN DRUGS

Gita Chaurasia*

ABSTRACT

An orphan drug is defined as a medicine, vaccine or in vivo diagnostic agent intended to treat, prevent or diagnose a rare disease or not commercially viable to supply to treat, prevent or diagnose another disease or condition. This paper gives an idea about Innovation and the Orphan Drug Act which provides some incentives like grants funding, performance of clinical trials and credit of tax on clinical cost and create exclusive right of marketing. Prior research has been done on various aspects of the Orphan Drug Act. A few studies provided perspectives on the early implementation of the incentive. Some orphan drugs are enlisted in the paper designated by TGA. The EURORDIS Round Table of Companies (ERTC), FDA, TGA and Office of Orphan Product Development (OOPD) help to manage regulatory function of orphan drugs. They found that the drugs averaged about 8 years in clinical development (from Investigational New Drug [IND] to New Drug Application [NDA]) and approximately 1.8 years in FDA review.

Keywords: orphan drugs, EURORDIS, clinical development.


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