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Feeding next-generation nanomedicines to europe: regulatory and quality challenges

This approach could transform the landscape of heart disease management, offering hope for millions and redefining heart health strategy

Like if you're if you're exercising, for example, how fast does your heart rate recover

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

The rule was meant to solve scarcity, not subsidize unmet demand