UAE accelerates rare disease medicine approvals

In a significant policy update, the UAE Ministry of Health and Prevention (MoHAP) has launched an accelerated pathway for the registration and approval of medicines for rare diseases. This initiative aims to provide patients in the UAE with faster access to breakthrough treatments that are already approved by international bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This move directly impacts residents who require specialised, often life-saving, medications that were previously subject to lengthy local approval processes. The new system is designed to reduce waiting times and potentially lower the high costs associated with importing these drugs on an individual basis. ## What changed? MoHAP has established a new "Fast-Track" registration process specifically for medicines that treat rare diseases. Previously, all new drugs, regardless of their status with other global regulators, underwent an extensive evaluation process in the UAE that could take several months. Under the new regulation, medicines that have already secured approval from the FDA or EMA can be registered in the UAE through an expedited review. According to MoHAP, this will shorten the assessment period significantly. For instance, a new orphan drug for a rare genetic disorder, once approved in the US, can now be made available to patients in the UAE much more quickly. This includes specific treatments for conditions like spinal muscular atrophy, cystic…