Quality & Compliance
Safety & Vigilance
04 january 2024
The intention must be for the treatment, prevention, or diagnosis of a disease that is rare disease or life-threatening, or chronically debilitating;
Orphan drug designation is a status granted by regulatory agencies to pharmaceuticals and biologics developed to treat rare diseases or conditions. Here are some benefits of orphan drug designation:
1. Market Exclusivity
2. Financial Incentives
3. Extended Patent Protection
4. Accelerated Approval
5. Grants and Funding
6. Public Recognition
7. Assistance with Clinical Trials
8. Higher Pricing Flexibility
9. Potential for Future Expansion
Note: These criteria are based on the guidelines provided by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other similar agencies.
Distribution of orphan designations per disease area
Orphan designations in the EU and US released per year
Distribution of indications in the EU and US per age groups. Legend: label not available for 7 ODDs
We at PLG have an efficient team of experts who cannot only guide you through the possibilities and advise you for the best outcome but can file submissions for orphan drug designation and help at every stage required.
We at PLG have an efficient team of experts who cannot only guide you through the process and the possibilities and advise you for the best outcome but also file submissions for orphan drug designation and help at every stage required. Our clinical and regulatory experts will support you in designing a scientifically comprehensive and regulatory-compliant dossier for your planned orphan designation. Our experts can also support you in managing any regulatory meetings related to the ODD. We can also hold and maintain the Orphan drug designation on your behalf if required.
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