Our briefing provides an overview of the post-Brexit regulatory pathway for Advanced Therapy Medicinal Products (ATMPs) in the UK and highlights some key challenges.
Advanced Therapy Medicinal Products are complex medicines for human use that are based on genes, tissues or cells. Rather than treating symptoms, ATMPs target the underlying causes of disease. They may be personalised for each patient.
Regulating Advanced Therapy Medicinal Products in the UK after Brexit provides an introduction to ATMPs and their applications, explores the EU and UK regulatory and governance pathway, and outlines the key changes resulting from the UK’s departure from the EU.
The briefing will be of interest to those involved in biotechnology, medical regulation, medical marketing, pharmaceuticals, policy making, patient advocacy as well as other providers of healthcare.
Advanced Therapy Medicinal Products offer new opportunities for treating diseases but a range of challenges complicate their translation from research to clinical use. These therapies tend to be very expensive, with complex manufacturing procedures and demanding regulatory approval processes. Having left the EU, the UK is in a position to consider new creative solutions to identify and address bottlenecks that might inhibit the opportunities arising from ATMPs.
The full briefing is available to download here.
