Abstract
Orphan drugs are developed to treat rare diseases. Some regulatory bodies established orphan drug designation with incentives to help pharmaceutical companies to develop orphan drugs. However, there is a lack of pre-marketing safety data for orphan drugs because limited number of patients involved, due to the rarity of the diseases. Considering that post-marketing long-term safety of orphan drugs still uncertain and the low utilization profile which make it challenging to monitor the safety of orphan drugs.The Saudi Food and Drug Authority (SFDA) initiated a project to monitor the safety of orphan drugs registered.
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