Generic placeholder image

Applied Clinical Research, Clinical Trials and Regulatory Affairs

Editor-in-Chief

ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

Nanotechnology: Regulatory Outlook on Nanomaterials and Nanomedicines in United States, Europe and India

Author(s): Rashi Malik* and Sharvil Patil*

Volume 7, Issue 3, 2020

Page: [225 - 236] Pages: 12

DOI: 10.2174/2213476X06666191129094236

conference banner
Abstract

Background: The outlook on “Nano-materials, products, medicine and technology” lacks a consensus on the definition to be considered by regulatory bodies all over the world. Engineered nanoparticles, the formulated products containing nanomaterials, are not subject to any precise regulation pertaining to production, handling and labeling till now. Also, nano medicines holding an immense potential involved in treatment and diagnosis with emerging research, yet, lag behind with unnoticed concerns regarding their safety and toxicity. Therefore, a regulatory framework focused on specific guidelines for products with the application of nanotechnology is being designed for extending the immense benefits of nanomedicines to humanity. Regulatory bodies have taken the forefront in dealing with the risks associated with nanomedicines, including the United States Environment Protection Agency (EPA) and the US Food and Drug Administration (USFDA), and the Health and Consumer Protection Directorate of the European Commission (EC).

Objective: The study aimed to depict the current status and suggest future perspectives of nanomedicine, by compiling the guidance of different regulatory bodies, thereby, eliminating the vagueness of nanotechnology in regulatory terms.

Conclusion: Ambiguity continues to prevail considering the regulations and safety of nanomaterials. Therefore, it becomes vital to facilitate the harmonization of assessment practices for nanomaterials with a unanimous opinion. On global level, OECD and its Working Party are currently dealing with manufactured nanomaterials.

Keywords: Nanomaterials, nanotechnology, regulations, nanoparticles, unanimous opinion, nanomedicines.

Graphical Abstract
[1]
Gelperina S, Kisich K, Iseman MD, Heifets L. The potential advantages of nanoparticle drug delivery systems in chemotherapy of tuberculosis. Am J Respir Crit Care Med 2005 Dec; 15172(12): 1487-90. Available from: http://www.ncbi.nlm.nih.gov/pubmed/1615104010.1164/rccm.200504-613PP
[2]
Malec M. A Regulatory Framework for Nanotechnology 2018; 1-256. Available from: https://www.hsaj.org/articles/14554
[3]
Ponce A. The EU Approach to Regulating Nanotechnology SSRN 2013; 1-46.
[http://dx.doi.org/10.2139/ssrn.2264056]
[4]
Rajneesh Kumar Gaur. Regulation of Nanomedicines Possible challenges Available from: https://www.pharmafocusasia.com/strategy/regulation-nanomedicines
[5]
Jeevanandam J, Barhoum A, Chan YS, Dufresne A, Danquah MK. Review on nanoparticles and nanostructured materials: history, sources, toxicity and regulations. Beilstein J Nanotechnol 2018; 9: 1050-74.
[http://dx.doi.org/10.3762%2Fbjnano.9.98] [PMID: 29719757]
[6]
FDA’s approach to regulation of nanotechnology products | FDA. Available from: https://www.fda.gov/science-research/nanotechnology-programs-fda/fdas-approach-regulation-nanotechnology-products
[8]
Guidance for Industry Considering Whether an FDARegulated Product Involves the Application of Nanotechnology 2014. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considering-whether-fda-regulated-product-involves-application-nanotechnology
[9]
FDA. Drug products, including biological products that contain nanomaterials guidance for industry guide Ind 2017. Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
[10]
Flinders Consulting Pty. Pidd K, Australian Safety and Compensation Council. A review of the potential occupational health and safety implications of nanotechnology 2006. Available from: https://www.fda.gov/science-research/nanotechnology-programs-fda/nanotechnology-task-force-report-2007
[11]
National nanotechnology initiative strategic plan National Science and Technology Council Subcommittee on Nanoscale Science , Engineering , and Technology Committee on Technology 2014. Available from: https://www.nano.gov/sites/default/files/pub_resource/2014_nni_strategic_plan.pdf
[13]
National Nanotechnology Initiative. Environmental, health, and safety research strategy 2011. Available from: http://www.nano.gov/sites/default/files/pub_resource/nni_2011_ehs_research_strategy.pdf
[14]
Toney HM. Promulgation of Environmental Protection 2017; 82(8): 41-55.
[15]
Electronic drug registration and listing instructions | FDA . [cited: 2019, May 28] Available from: https://www.fda.gov/drugs/drug-registration-and-listi-ng/electronic-drug-registration-and-listing-instructions
[16]
Definition - nanomaterials - environment - european commission. Available from: http://ec.europa.eu/environment/chemicals/nanotech/faq/definition_en.htm
[17]
EUR-Lex - 32011H0696 - EN - EUR-Lex; [cited: 2019, May 21]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011H0696
[18]
Rauscher H, Roebben G, Sanfeliu AB, et al. JRC science for policy report towards a review of the EC recommendation for a definition of the term “nanomaterial” 2015.
[http://dx.doi.org/10.2788/678452]
[19]
EUR-Lex - 52012DC0572 - EN - EUR-Lex; . [cited 2019 May 22]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52012DC0572
[20]
Ponce D, Castillo AM. The European and member states’ approaches to regulating nanomaterials: Two Levels of Governance. NanoEthics 2013; 7(3): 189-99.
[http://dx.doi.org/10.1007/s11569-013-0181-7]
[21]
Nanomaterials in REACH and CLP - environment - European commission. [cited 2019 May 23]. Available from: http://ec.europa.eu/environment/chemicals/nanotech/reach-clp/index_en.htm
[22]
Nanomaterials – ECHA;. [cited 2019 May 21] Available from: https://echa.europa.eu/regulations/nanomaterials
[23]
EMEA. Reflection paper on nanotechnology-based medicinal products for human use 2006. Available from: https://www.ema.europa.eu/en/documents/presentation/presentation-quality-aspects-nano-based-medicines-dolores-hernan-pacrez-de-la-ossa_en.pdf
[25]
EFSA. The appropriateness of the risk assessment methodology in accordance with the technical guidance documents for new and existing substances for assessing the risks of nanomaterials Environment 2007. Available from: http://ec.europa.eu/health/ph_risk/risk_en.htm
[26]
Prepared reflection paper on nanotechnology-based medicinal products for human use. Eur Med Agency Guidelines for Evaluation of Nanopharmaceuticals in India Available from: https://etp-nanomedicine.eu/wp-content/uploads/2018/10/reflection-paper-nanotechnology-based-medicinal-products-human-use_en-1.pdf
[27]
Maclurcan D, Radywyl N. Nanotechnology and global sustainability. 1st ed. New York: CRC Press 2012; p. 307.
[http://dx.doi.org/10.1201/b11833 ]
[28]
Guidelines and best practices for safe handling of nanomaterials in research laboratories and industries nano mission, DST, Govt of India by (with inputs from nanoregulatory task force). Available from: https://dst.gov.in/sites/default/files/Draft-Guidelines%20.pdf
[29]
Beaudrie CEH, Kandlikar M. From Cradle-to-Grave at the Nanoscale: Gaps in US Regulatory Oversight along the Nanomaterial Life Cycle. Enviro Sci Technology 2013; 47(11)
[http://dx.doi.org/10.1021/es303591x]
[30]
Park H-G, Yeo M-K. Nanomaterial regulatory policy for human health and environment 2016. Available from: http://link.springer.com/10.1007/s13273-016-0027-9
[http://dx.doi.org/10.1007/s13273-016-0027-9]
[31]
Report of the scientific conference: Science Based Support for Regulation of Manufactured Nanomaterials Organised by Prosafe and hosted by the OECD 2016; 1-84.

© 2024 Bentham Science Publishers | Privacy Policy