REGULATORY ROADMAP FOR NANOTECHNOLOGY BASED MEDICINES
Abstract
Nanotechnology is emerging as one of the key technologies of the 21st century and is expected to enable developments across a wide range of sectors that can benefit citizens. Nanomedicine is an application of nanotechnology in the areas of healthcare, disease diagnosis, treatment and prevention of disease. Nanomedicines pose problem of nanotoxicity related to factors like size, shape, specific surface area, surface morphology, and crystallinity. Currently, nanomedicines are regulated as medicinal products or as medical devices and there is no specific regulatory framework for nanotechnology-based products neither in the EU nor in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.
Keywords:
Nanotechnology, Nanomedicine, Nanotoxicity, Approval, Regulations.
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References
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2. Service RF. Atom-Scale Research Gets Real; Outlook for Nanotechnology. Sci. 2000; 290:1523-26.
3. Smith CW, Smith CM. Atomic Force Microscopy. The Scientist. 2001; 15:23.
4. What is so special about nanoscale; [Internet]. US; 2010 [cited 2014 Aug 13]. Available from:
http://www.nano.gov/nanotech-101/special
5. What’s so special about the nanoscale [Internet]. Semantic personal publishing platform; 2012 Oct 12 [cited 2014 Sept 11]. Available from:
http://www.bionano.com/?p=260
6. Avouris P, Appenzeller J. Electronics and optoelectronics with carbon nanotubes: New discoveries brighten the outlook for innovative technologies. The Industrial Physicist, American Institute of Physics [Internet]. 2004 [cited 2014 Sept 11]. Available from:
http://www.slideshare.net/AllianzKnowledge/opportunities-and-risks-of-nanotechnologies
7. Iqbal MJ. Carbon Nanotubes: Delivery systems for anticancer drugs. J Ras Lat Med Col. 2013; 2:1-4.
8. Bawa R. Special report- patents and nanomedicine. Nanomedicine. 2007; 2(3): 351-74.
9. Bawa R. Patenting inventions in bionanotechnology: a primer for scientists and lawyers. In: Reisner DE, Bionanotechnology: Global Prospects. CRC Press, FL; 2009 .p. 309-37.
10. Nanotechnology in medical devices [Internet]. 2004 [cited 2014 Sept 24]. Available from:
http://www.mhra.gov.uk/home/groups/comms-con/.../con2022822.pdf
11. How we regulate nanotechnology [Internet]. 2013 [cited 2014 Sept 23]. Available from:
http://www.mhra.gov.uk/Howweregulate/Nanotechnology/
12. National Nanotechnology Initiative. United States: National Nanotechnology Initiative [Internet]. 2011 [cited 2014 Sept 22]. Available from:
http://www.nano.gov/
13. Yun Y. Nanomedicine Design of Particles, Sensors, Motors, Implants, Robots, and Devices in Chapter 9- Nanomedicine. Artech House; 2009 .p. 240-45.
14. Igami M, Okazaki T. Capturing Nanotechnology's Current State of Development via 7 Analysis of Patents. OECD Science, Technology and Industry Working Papers; 2007.
15. European Science Foundation. Nanomedicine - An ESF -European Medical Research Counsils forward look report. France: Strasboourg cedex; 2004.
16. Freitas R. Nanomedicine [Internet]. 1999 [cited 2014 Sept 12]. Available from:
http://www.foresight.org/Nanomeicine
17. Bionanotechnology: Global Prospects. Edt: David Reisner. CRC Press; 2008.p.1-5
18. Bawa R. FDA and Nanotech: Baby Steps Lead to Regulatory Uncertainty. Bio-Nanotechnology: A Revolution in Food, Biomedical and Health Sciences; First Edition. John Wiley & Sons, Ltd.; 2013.p.721-32.
19. Bawa R. Regulating Nanomedicine - Can the FDA Handle It? Current Drug Delivery. 2011; 8:227-34.
20. Albany. [Internet] New York, Newswire: 2014 [cited 2014 Sept 27]. Available from:
http://www.transparencymaketresearch.com
21. Flynn T, Wei C. The pathway to commercialization for nanomedicine. Nanomed Nanotech Biol Med. 2005; 1:47-51.
22. Gupta VK. Indian patents output in nanotechnology. Journal of Intellectual Property Rights. 2009; 14:164-65.
23. Dang Y, Zhang Y, Fan L. et al. Trends in worldwide nanotechnology patent applications. J Nanopart Res. 2010; 12:687-706.
24. Wagner V. Nanomedicine: Drivers for development and possible impacts. European Commission; 2008.
25. Stemplewski H. Nanomedicines: A regulatory perspective. MRC Centre for Drug Safety Science Workshop; 2010.
26. Yen SK, Padmanabhan P, Selvan ST: Multifunctional Iron Oxide Nanoparticles for Diagnostics, Therapy and Macromolecule Delivery. Theranostics. 2013; 3(12):986–1003.
27. Kuzma J, Priest S. Nanotechnology, risk, and oversight: learning lessons from related emerging technologies. Risk Analysis. 2010; 30(11):1688–98.
28. US FDA. Nanotechnology: a report of the U.S. Food and Drug Administration Nanotechnology Task Force; 2007.
29. Miller J. Beyond Biotechnology: FDA Regulation of Nanomedicine. vol. Iv. The Columbia Science and Technology Law Review; 2013.
30. FDA Inter center Agreement between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Food & Drug L Rep. 1992; 29(2):8.
31. FDA Intercenter Agreement between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health (Oct. 31, 1991), reprinted in FDLI, 3 Food & Drug L Rep. No. 2, at 44 (Supp. Feb. 1992).
32. FDA plan for statutory compliance [Internet]. 1998 [cited 2014 Sept 24]. Available from:
http://www.fda.gov/.../FDAMA/FDAPlanforStatutoryCompliance/ucm114047
33. Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 16, 104 Stat. 4511, 4526 (codified as amended at21 U.S.C. § 353 (1994)).
34. Food and Drug Modernization Act § 416, 21 U.S.C § 360bbb-2 ;2003.
35. Miller JC, Serrato R, Represas JM. The Handbook of Nanotechnology: Business, Policy, and Intellectual Property Law; 2004.
36. Medical Devices Act. USFDA. [Internet]. 1999 [cited 2014 Sept 12]. Available from:
http://www.fda.gov/MedicalDevices
37. Pathak P, Katiyar VK. Multi-functional nanoparticles and their role in cancer drug delivery - a review. [Internet]. 2007 [cited 2014 Oct 12]. Available from:
http://www.azonano.com/article.aspx?ArticleID=1903
38. FDA Plan for Statutory Compliance [Internet]. 2008 Nov [cited 2014 Oct 11]. Available from:
http://www.fda.gov/.../Legislation/.../FDAMA/FDAPlanforStatutoryComplianc
39. Linkov I. Nanomedicine: Nanotechno- logy, Biology, and Medicine. 2008; 4:167–71.
40. Naahidi S, Jafari M, Edalat F. et al. Biocompatibility of engineered nanoparticles for drug delivery. Journal of Controlled Release. 2013; 166:182–94.
41. Chidambaram M, Krishnasamy K. Nanotoxicology: Toxicity of engineered nanoparticles and approaches to produce safer nanotherapeutics. International Journal of Pharma Sciences. 2012; 2(4):117-22.
42. Moghimi SM, Hunter CA, Murray JC: Nanomedicine: current status and future prospects. FASEB. 2005; 19(3):311-30.
43. Ventola CL. The Nanomedicine Revolution Part 3: Regulatory and Safety Challenges. 2012; 37(11):631-39.
44. Paradise J. The FDA, nanodrugs, and implications for healthcare. Presented at the American Society of Law, Medicine & Ethics 32nd Annual Health Law Professors Conference. Cleveland; 2009 Jun 5.
45. The Loka Institute. Principles for the Oversight of Nanotechnologies and Nanomaterials. International Center for Technology Assessment (ICTA); 2007.
46. Poirot-Mazères I. Legal aspects of the risks raised by nanotechnologies in the field of medicine. J Int Bioethique. 2011; 22(1):99–118.
47. FDA. Science & Research. Nanotechnology Task Force Report [Internet]. 2007 [cited 2014 Oct 02].. Available from:
http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/UCM2006659.htm.
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How to Cite
Limaye, V., G. Fortwengel, and D. Limaye. “REGULATORY ROADMAP FOR NANOTECHNOLOGY BASED MEDICINES”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 4, Feb. 2018, pp. 33-41, doi:10.22270/ijdra.v2i4.151.
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