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Orphan designation Key concepts and evaluation criteria Workshop for Micro, Small and Medium sized Enterprises Focus on scientific and regulatory advicePresented by: Jordi Linear Head of orphan medicines'
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What is orphan designation?
Orphan designation is a status granted to a drug or biologic that is intended to treat a rare disease or condition, defined as affecting fewer than 200,000 individuals in the United States.
Who is required to file orphan designation?
The sponsor or manufacturer of a drug or biologic is required to file for orphan designation with the regulatory authorities such as the FDA in the United States or the EMA in Europe.
How to fill out orphan designation?
To fill out orphan designation, the sponsor needs to provide information such as the name of the drug, the rare disease or condition it intends to treat, data supporting the prevalence of the disease, and a rationale for why the drug would provide a significant benefit.
What is the purpose of orphan designation?
The purpose of orphan designation is to incentivize the development of drugs for rare diseases by providing certain benefits and market exclusivity to the sponsor, encouraging investment in research and development.
What information must be reported on orphan designation?
The information reported on orphan designation includes the drug name, the rare disease or condition it targets, data on the prevalence of the disease, information on the drug's mechanism of action, as well as its potential benefit over existing treatments.
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