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In the UK, the pathway to approval typically involves: Submission of a Marketing Authorisation Application (MAA) to the MHRA Scientific review of clinical trial data, including safety, efficacy, and quality data Benefit-risk assessment by MHRA experts If approved, a subsequent NICE technology appraisal to determine whether the medicine represents value for money and should be made available within the NHS The MHRA also operates an Early Access to Medicines Scheme (EAMS) , which can allow patients with life-threatening or seriously debilitating conditions to access promising unlicensed medicines before full approval