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

Abstract

As the market for nanomedicines in the EU is growing, the development of regulatory guidance in this area assumes priority. Currently, the nanomedicine market is poised at a critical stage wherein clear regulatory guidance is imperative in providing for clarity and legal certainty to manufacturers of nanomedicine. The regulation of the pharmaceutical sector in the EU has witnessed several developments and innovations guided by the philosophy of single market and balancing the principle of ensuring high public health protection and safety of medicines. Both the pediatric and the advanced therapies medicinal products (ATMP) regimes offer important regulatory guidance that could be adopted for the regulation of nanomedicines in the EU.