Is New Zealand’s Regulation of Nanomedicines Adequate?
This article investigates the adequacy of New Zealand's regulation of medical products produced by nanotechnology and containing nanomaterials. There is concern that the novel and unique properties of some nanoscale chemical substances will bring unforeseen human and environmental health and safety risks. Given the possible market for nanomedicines and their potential risks, it is important to have adequate regulation of nanomedicines in order to prevent adverse public health ramifications. This article argues that nanoparticles, invisible to the human eye, are illuminating and exacerbating, legislative imperfections in the Medicines Act 1981 (NZ). This Act does not include a pre-market approval process for medical devices, nor does it include provisions for combination products. This approach is inconsistent with international norms. The article proposes amendment of the Medicines Act 1981 (NZ) to address these weaknesses and the novel challenges posed by nanomedicines.
Publisher: Thomson Reuters
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Keywords: nanomedicine; regulation of nanotechnology; medicines legislation; medical devices; pharmaceuticals; risk
Research Type: Journal Article