Regulation of nanomedicines in the EU: distilling lessons from the pediatric and the advanced therapy medicinal products approaches

This article looks at the regulatory system in the European Union for pharmaceuticals, and the developments and innovations that have taken place guided by the philosophy of single market and balancing the principles of ensuring high public health protection and the safety of medicines. After examining these developments, she discusses how the pediatric and advanced therapies medical products regimes offer important regulatory guidance that could be adopted for the regulation of nanomaterials.