Regulatory roadmap for nanotechnology based medicines

  • 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.

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Metadaten
Author:Vaidehi Limaye, Gerhard Fortwengel, Dnyanesh Limaye
URN:urn:nbn:de:bsz:960-opus4-10835
Document Type:Article
Language:English
Year of Completion:2014
Release Date:2017/05/30
Tag:Approval; Nanomedicine; Nanotechnology ; Nanotoxicity; Regulations
Volume:2014
Issue:2(4)
First Page:33
Last Page:41
Institutes:Fakult├Ąt III - Medien, Information und Design
Dewey Decimal Classification:610 Medizin, Gesundheit
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell 4.0