Advanced therapy regulation in the UK: what might the future hold post-Brexit?

The development of Advanced Therapy Medicinal Products (ATMPs) in the European Union (EU) is subject to a unique ‘patchwork’ of associated but distinct European regulations and directives. However, the UK’s exit from the EU has provided an opportunity to evaluate all medicines legislation that currently applies in the UK, including those governing the regulation of ATMPs. Despite the challenges and uncertainties associated with the UK’s exit from the EU, it is important to acknowledge that this change can create new opportunities from which the UK can benefit, whilst staying aligned to the EU. The UK can take the opportunity to orient its legislation and associated procedures towards the unique requirements of ATMPs throughout their life-cycle; from the procurement of cell and tissue-based starting materials, the Gene Modified Organism (GMO) legislation through to manufacture, licensure and adoption. This paper discusses where, if at all, the UK might diverge or expand from the EU regulatory framework for ATMPs and what challenges and advantages this might bring.

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