ARM engages with the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to advance future-facing regulatory frameworks through leadership engagement and shared policy development.
ARM is working with EMA to identify opportunities for practical regulatory convergence.
ARM engages with the European Medicines Agency (EMA) and the Committee for Advanced Therapies (CAT) to advance regulatory frameworks for gene editing platforms, ensuring that scientific innovation is matched with clear, predictable guidance.
ARM is working with the UK MHRA to shape a regulatory framework for platform technologies in rare diseases, enabling adaptive approaches that leverage prior knowledge while maintaining high standards of safety and access.
ARM regularly comments on EMA regulatory guidance, rules, and other policies that impact cell and gene therapy.
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