Taking Temperature – A Review of European Union Regulation in Nanomedicine
Joel D’Silva, Institute of Environmental and Energy Law
Geert Van Calster, K.U.Leuven
October 15, 2008
Nanomedicine, the application of nanotechnology to healthcare offers numerous improvements to medical diagnosis, drug delivery, therapy and implants. The potential impact of nanomedicine is foreseen radically to change health care; however it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance. This paper introduces the emerging field of nanomedicine and then proceeds to detail the current regulatory framework and regulatory bodies in the European Union relating to medicinal products, medical devices, biologics and therapies. This is followed by a detailed analysis of two nanomedical applications in the context of regulatory challenges. The paper concludes with a discussion of the adequacy of the current regulatory regime in Europe and where problems are likely to arise as nanomedicine evolves.