The challenges of regulating stem cell-based products.

Appropriate regulation of stem cell-based products is essential to ensure public safety and trust while minimising unnecessary barriers to product development, but presents numerous challenges. Weaknesses of existing legal frameworks include variation between jurisdictions and poor fit between product categories and new technologies. The new European Regulation on advanced therapy medicinal products is an important attempt to provide a consolidated regulatory framework for novel products. Others can learn from issues encountered in its development, including definition of product categories, ethical concerns, and the application of regulations to small-scale production. Several aspects of the Regulation will be useful models, but some larger questions remain unresolved. As reform efforts move forward, harmonisation and sharing of expertise will be vital to effective regulation.