Orphan Drugs

Orphan Drugs are medicines for rare diseases which, under normal circumstances, would not be developed by pharmaceutical companies because they would be unable to recoup their costs. The EU and the FDA, however, have provided a range of incentives to encourage companies to develop orphan medicines.  To benefit from the incentives offered by the EU, individuals or companies have to submit an application to the EMEA to request "orphan designation" for their medicine. Once the medicine is awarded "orphan drug" status, the individual or company can then take full advantage of the incentives on offer. These incentives include:

Global Regulatory Services can help you to determine whether or not you can apply for your medicine to have "orphan drug" status. You can then take advantage of the incentives listed above and maximise your return on investment. At the same time, you will be improving the quality of life of those patients who suffer rare diseases.

 
Please contact us with your specific regulatory compliance requirements.

 

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