In this webinar, Richard Huckle explores expedited programmes and expanded access schemes beyond the US and EU to get medicines faster to patients with unmet need. There has been much attention recently on the FDA’s Breakthrough Therapy Designation (BTD) and EMAs PRIME scheme to accelerate regulatory review and approval, do other markets have similar pathways? For unapproved medicines, clinical trials were the only way to access new drugs under development. However, not every patient meets the enrolment criteria, and participation is difficult for patients with unmet need. Early access programmes such as a Compassionate Use Programme (CUP) have generated alternative channels for such patients (and all important real world data for the developer). As soon as a novel medicine shows promise in the treatment of rare, life-threatening, long-lasting or seriously debilitating diseases a CUP should feature in the development plan.
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