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International Harmonization of Regulation of Nanomedicine

Studies on Ethics, Law, and Technology, 2009

14 Pages Posted: 21 Oct 2009 Last revised: 30 Mar 2013

Gary E. Marchant

Arizona State University - College of Law

Douglas J. Sylvester

Arizona State University - College of Law

Kenneth W. Abbott

Arizona State University

Tara Lynn Danforth

Center for Law, Science, & Technology

Date Written: October 20, 2009

Abstract

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether there are mechanisms of international harmonization or cooperation that can facilitate the development of more effective and efficient regulatory regimes for nanomedicine?

Part I of this paper briefly summarizes the promise of nanomedicine as well as potential concerns about the risks of nanomedical applications that will require regulatory oversight. In Part II, we analyze the various factors weighing for and against attempts to harmonize regulatory requirements at the international level. Finally, in Part III we identify some specific existing or feasible mechanisms that may be useful for fostering international harmonization in the regulation of nanomedicine.

Keywords: nanotechnology, regulation, technology, biotechnology, EPA, FDA, NIOSH, risk, medicine, nanomedicind, ethics, harmonization

Suggested Citation

Marchant, Gary E. and Sylvester, Douglas J. and Abbott, Kenneth W. and Danforth, Tara Lynn, International Harmonization of Regulation of Nanomedicine (October 20, 2009). Studies on Ethics, Law, and Technology, 2009 . Available at SSRN: https://ssrn.com/abstract=1491782

Gary E. Marchant

Arizona State University - College of Law ( email )

Box 877906
Tempe, AZ 85287-7906
United States
(480) 965-3246 (Phone)
(480) 965-2427 (Fax)

Douglas J. Sylvester (Contact Author)

Arizona State University - College of Law ( email )

Box 877906
Tempe, AZ 85287-7906
United States

Kenneth Wayne Abbott

Arizona State University ( email )

Box 877906
Tempe, AZ 85287-7906
United States
480-965-5917 (Phone)

Tara Lynn Danforth

Center for Law, Science, & Technology ( email )

Box 877906
Tempe, AZ 85287-7906
United States

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