Nano Archive

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

Chowdhury, Nupur (2010) Regulation of nanomedicines in the EU: distilling lessons from the pediatric and the advanced therapy medicinal products approaches. Nanomedicine (London, England), 5 (1). pp. 135-142. ISSN 1748-6963

[img]
Preview
PDF - Published Version
410Kb

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.

Item Type:Article
Uncontrolled Keywords:advanced therapy medicinal products - efficacy - internal market - market authorization - nanomedicine - pediatrics - safety regulation
Subjects:Social and Political Science > Policy developments with respect to nanotechnology
Biomedical Science > Nanotechnology for human health
Risk > Environment, health and safety aspects of nanotechnology
Biomedical Science > Nanomedicine
ID Code:9224
Deposited By:Lesley Tobin
Deposited On:02 Jun 2010 10:40
Last Modified:02 Jun 2010 10:40

Repository Staff Only: item control page