Taking temperature--a review of European Union regulation in nanomedicine.

Full Abstract

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.

Author information

Author/s: D'Silva, Joel (J); van Calster, Geert (G);

Affiliation: Faculty of Law, K.U. Leuven, Belgium. joel.dsilva(-atsign-)law.kuleuven.be

Journal and publication information

Publication Type: Journal Article

Journal: European journal of health law (Eur J Health Law), published in Netherlands. (Language: eng)

Reference: 2009-Sep; vol 16 (issue 3) : pp 249-69

Dates: Created 2009/09/30; Completed 2009/10/29;

PMID: 19788003, status: MEDLINE (last retrieval date: 10/29/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

External Links for this article
(including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.