Nanotechnology and nanomedicine in market: a global perspective on regulatory issues

Sheila Devasahayam

doi:10.1016/B978-0-12-814031-4.00017-9

Nanotechnology and nanomedicine in market: a global perspective on regulatory issues

Sheila Devasahayam^*

^*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

16 Citations (Scopus)

Abstract

Perceived adverse effects of nanoscience and nanotechnologies (NTs) on health, safety, and environment (EHS) can impede the progress, competitiveness, and responsible and sustainable development of NT across a wide range of industrial sectors. Studies on the interaction of man-made nanostructured materials and living organism are still in their infancy.

Opportunities and innovative products of NTs in the health sector are coming, along with challenges in the regulation of these products, posing great challenges to existing legislative frameworks. The predominant areas of use of NT in medicine, classified as nanomedicine, are in drug delivery and as diagnostic imaging and biosensors.

Current fragmented regulatory regimes across the world, though considered adequate, have potential gaps that prevent comprehensive regulation of NT. There is a general consensus for an internationally integrated NT governance to address the ethical, legal, and social aspects of the NT.

Legal metrology's (LM's) scope concerning the EHS and trade measurements seems to be the ideal platform to address the impact of NT. This work explores the feasibility of LM as a platform to address the impact of NT on EHS, legal, and socioeconomic aspects. LM's objectives relate to harmonized regulation and measurements, not exclusively to measurement range or technology, such as macro, micro, meso, nano, or space and biotechnologies.

Original language	English
Title of host publication	Characterization and biology of nanomaterials for drug delivery
Subtitle of host publication	nanoscience and nanotechnology in drug delivery
Editors	Shyam S. Mohapatra, Shivendu Ranjan, Nandita Dasgupta, Raghvendra Kumar Mishra, Sabu Thomas
Place of Publication	Amsterdam; Oxford, UK; Cambridge, US
Publisher	Elsevier
Chapter	17
Pages	477-522
Number of pages	46
ISBN (Electronic)	9780128140321
ISBN (Print)	9780128140314
DOIs	https://doi.org/10.1016/B978-0-12-814031-4.00017-9
Publication status	Published - 2019

Publication series

Name	Micro and Nano Technologies Series
Publisher	Elsevier

Keywords

Harmonized global regulatory framework
Health
Legal metrology
Nanomedicine
Nanometrology
Safety and environment

Access to Document

10.1016/B978-0-12-814031-4.00017-9

Cite this

Devasahayam, S. (2019). Nanotechnology and nanomedicine in market: a global perspective on regulatory issues. In S. S. Mohapatra, S. Ranjan, N. Dasgupta, R. K. Mishra, & S. Thomas (Eds.), Characterization and biology of nanomaterials for drug delivery: nanoscience and nanotechnology in drug delivery (pp. 477-522). (Micro and Nano Technologies Series). Elsevier. https://doi.org/10.1016/B978-0-12-814031-4.00017-9

Devasahayam, Sheila. / Nanotechnology and nanomedicine in market : a global perspective on regulatory issues. Characterization and biology of nanomaterials for drug delivery: nanoscience and nanotechnology in drug delivery. editor / Shyam S. Mohapatra ; Shivendu Ranjan ; Nandita Dasgupta ; Raghvendra Kumar Mishra ; Sabu Thomas. Amsterdam; Oxford, UK; Cambridge, US : Elsevier, 2019. pp. 477-522 (Micro and Nano Technologies Series).

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abstract = "Perceived adverse effects of nanoscience and nanotechnologies (NTs) on health, safety, and environment (EHS) can impede the progress, competitiveness, and responsible and sustainable development of NT across a wide range of industrial sectors. Studies on the interaction of man-made nanostructured materials and living organism are still in their infancy. Opportunities and innovative products of NTs in the health sector are coming, along with challenges in the regulation of these products, posing great challenges to existing legislative frameworks. The predominant areas of use of NT in medicine, classified as nanomedicine, are in drug delivery and as diagnostic imaging and biosensors. Current fragmented regulatory regimes across the world, though considered adequate, have potential gaps that prevent comprehensive regulation of NT. There is a general consensus for an internationally integrated NT governance to address the ethical, legal, and social aspects of the NT. Legal metrology's (LM's) scope concerning the EHS and trade measurements seems to be the ideal platform to address the impact of NT. This work explores the feasibility of LM as a platform to address the impact of NT on EHS, legal, and socioeconomic aspects. LM's objectives relate to harmonized regulation and measurements, not exclusively to measurement range or technology, such as macro, micro, meso, nano, or space and biotechnologies.",

keywords = "Harmonized global regulatory framework, Health, Legal metrology, Nanomedicine, Nanometrology, Safety and environment",

author = "Sheila Devasahayam",

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Devasahayam, S 2019, Nanotechnology and nanomedicine in market: a global perspective on regulatory issues. in SS Mohapatra, S Ranjan, N Dasgupta, RK Mishra & S Thomas (eds), Characterization and biology of nanomaterials for drug delivery: nanoscience and nanotechnology in drug delivery. Micro and Nano Technologies Series, Elsevier, Amsterdam; Oxford, UK; Cambridge, US , pp. 477-522. https://doi.org/10.1016/B978-0-12-814031-4.00017-9

Nanotechnology and nanomedicine in market: a global perspective on regulatory issues. / Devasahayam, Sheila.
Characterization and biology of nanomaterials for drug delivery: nanoscience and nanotechnology in drug delivery. ed. / Shyam S. Mohapatra; Shivendu Ranjan; Nandita Dasgupta; Raghvendra Kumar Mishra; Sabu Thomas. Amsterdam; Oxford, UK; Cambridge, US : Elsevier, 2019. p. 477-522 (Micro and Nano Technologies Series).

Research output: Chapter in Book/Report/Conference proceeding › Chapter › peer-review

TY - CHAP

T1 - Nanotechnology and nanomedicine in market

T2 - a global perspective on regulatory issues

AU - Devasahayam, Sheila

PY - 2019

Y1 - 2019

N2 - Perceived adverse effects of nanoscience and nanotechnologies (NTs) on health, safety, and environment (EHS) can impede the progress, competitiveness, and responsible and sustainable development of NT across a wide range of industrial sectors. Studies on the interaction of man-made nanostructured materials and living organism are still in their infancy. Opportunities and innovative products of NTs in the health sector are coming, along with challenges in the regulation of these products, posing great challenges to existing legislative frameworks. The predominant areas of use of NT in medicine, classified as nanomedicine, are in drug delivery and as diagnostic imaging and biosensors. Current fragmented regulatory regimes across the world, though considered adequate, have potential gaps that prevent comprehensive regulation of NT. There is a general consensus for an internationally integrated NT governance to address the ethical, legal, and social aspects of the NT. Legal metrology's (LM's) scope concerning the EHS and trade measurements seems to be the ideal platform to address the impact of NT. This work explores the feasibility of LM as a platform to address the impact of NT on EHS, legal, and socioeconomic aspects. LM's objectives relate to harmonized regulation and measurements, not exclusively to measurement range or technology, such as macro, micro, meso, nano, or space and biotechnologies.

AB - Perceived adverse effects of nanoscience and nanotechnologies (NTs) on health, safety, and environment (EHS) can impede the progress, competitiveness, and responsible and sustainable development of NT across a wide range of industrial sectors. Studies on the interaction of man-made nanostructured materials and living organism are still in their infancy. Opportunities and innovative products of NTs in the health sector are coming, along with challenges in the regulation of these products, posing great challenges to existing legislative frameworks. The predominant areas of use of NT in medicine, classified as nanomedicine, are in drug delivery and as diagnostic imaging and biosensors. Current fragmented regulatory regimes across the world, though considered adequate, have potential gaps that prevent comprehensive regulation of NT. There is a general consensus for an internationally integrated NT governance to address the ethical, legal, and social aspects of the NT. Legal metrology's (LM's) scope concerning the EHS and trade measurements seems to be the ideal platform to address the impact of NT. This work explores the feasibility of LM as a platform to address the impact of NT on EHS, legal, and socioeconomic aspects. LM's objectives relate to harmonized regulation and measurements, not exclusively to measurement range or technology, such as macro, micro, meso, nano, or space and biotechnologies.

KW - Harmonized global regulatory framework

KW - Health

KW - Legal metrology

KW - Nanomedicine

KW - Nanometrology

KW - Safety and environment

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U2 - 10.1016/B978-0-12-814031-4.00017-9

DO - 10.1016/B978-0-12-814031-4.00017-9

M3 - Chapter

SN - 9780128140314

T3 - Micro and Nano Technologies Series

SP - 477

EP - 522

BT - Characterization and biology of nanomaterials for drug delivery

A2 - Mohapatra, Shyam S.

A2 - Ranjan, Shivendu

A2 - Dasgupta, Nandita

A2 - Mishra, Raghvendra Kumar

A2 - Thomas, Sabu

PB - Elsevier

CY - Amsterdam; Oxford, UK; Cambridge, US

ER -

Devasahayam S. Nanotechnology and nanomedicine in market: a global perspective on regulatory issues. In Mohapatra SS, Ranjan S, Dasgupta N, Mishra RK, Thomas S, editors, Characterization and biology of nanomaterials for drug delivery: nanoscience and nanotechnology in drug delivery. Amsterdam; Oxford, UK; Cambridge, US : Elsevier. 2019. p. 477-522. (Micro and Nano Technologies Series). doi: 10.1016/B978-0-12-814031-4.00017-9

Nanotechnology and nanomedicine in market: a global perspective on regulatory issues

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