Beyond the Pharmaceutical Package: Using Regulatory Sandboxes to Test NTVMP Regulatory Logic within the ATMP Framework.

The regulation of advanced therapy medicinal products in the European Union relies on a definition-driven architecture designed to ensure legal certainty and a high level of patient protection. While effective for established technologies, this model increasingly struggles to accommodate emerging and hybrid therapeutic modalities that do not fit easily into existing legal categories. By contrast, EU veterinary pharmaceutical law has adopted a more flexible regulatory logic through the notion of novel therapy veterinary medicinal products. This article examines the normative divergence between these two frameworks and assesses whether elements of the veterinary approach could inform the future evolution of human medicines regulation. It argues that regulatory sandboxes should be understood not as ad-hoc legal experiments, but as a structured and reusable regulatory instrument, enabling selected veterinary-derived regulatory approaches to be assessed within EU human pharmaceutical law through controlled regulatory experimentation, while preserving legal certainty and patient protection.