Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

Jiun-Wen Guo,1 Yu-Hsuan Lee,2 Hsiau-Wen Huang,3 Mei-Chyun Tzou,3 Ying-Jan Wang,2 Jui-Chen Tsai1,4 1Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Chung Kung University, Tainan, Taiwan; 2Department of Environmental and Occupational Health, College of Medi...

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Autores principales: Guo JW, Lee YH, Huang HW, Tzou MC, Wang YJ, Tsai JC
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2014
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Medicine (General)
R5-920
Acceso en línea:https://doaj.org/article/641f6ec57fe24e7db5bc301a3c0356be
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spelling oai:doaj.org-article:641f6ec57fe24e7db5bc301a3c0356be2021-12-02T05:10:44ZDevelopment of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations1178-2013https://doaj.org/article/641f6ec57fe24e7db5bc301a3c0356be2014-10-01T00:00:00Zhttp://www.dovepress.com/development-of-taiwanrsquos-strategies-for-regulatingnbspnanotechnolog-peer-reviewed-article-IJNhttps://doaj.org/toc/1178-2013 Jiun-Wen Guo,1 Yu-Hsuan Lee,2 Hsiau-Wen Huang,3 Mei-Chyun Tzou,3 Ying-Jan Wang,2 Jui-Chen Tsai1,4 1Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Chung Kung University, Tainan, Taiwan; 2Department of Environmental and Occupational Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan; 3Food and Drug Administration, Ministry of Health and Welfare, Taiwan; 4Center for Pharmaceutical Regulatory Science, National Cheng Kung University, Tainan, Taiwan Abstract: Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. Keywords: CMC review, nanomedicine, nanotechnology, pharmaceuticals, regulatory guidanceGuo JWLee YHHuang HWTzou MCWang YJTsai JCDove Medical PressarticleMedicine (General)R5-920ENInternational Journal of Nanomedicine, Vol 2014, Iss Issue 1, Pp 4773-4783 (2014)
institution DOAJ
collection DOAJ
language EN
topic Medicine (General)
R5-920
spellingShingle Medicine (General)
R5-920
Guo JW
Lee YH
Huang HW
Tzou MC
Wang YJ
Tsai JC
Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
description Jiun-Wen Guo,1 Yu-Hsuan Lee,2 Hsiau-Wen Huang,3 Mei-Chyun Tzou,3 Ying-Jan Wang,2 Jui-Chen Tsai1,4 1Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Chung Kung University, Tainan, Taiwan; 2Department of Environmental and Occupational Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan; 3Food and Drug Administration, Ministry of Health and Welfare, Taiwan; 4Center for Pharmaceutical Regulatory Science, National Cheng Kung University, Tainan, Taiwan Abstract: Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. Keywords: CMC review, nanomedicine, nanotechnology, pharmaceuticals, regulatory guidance
format article
author Guo JW
Lee YH
Huang HW
Tzou MC
Wang YJ
Tsai JC
author_facet Guo JW
Lee YH
Huang HW
Tzou MC
Wang YJ
Tsai JC
author_sort Guo JW
title Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
title_short Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
title_full Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
title_fullStr Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
title_full_unstemmed Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
title_sort development of taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations
publisher Dove Medical Press
publishDate 2014
url https://doaj.org/article/641f6ec57fe24e7db5bc301a3c0356be
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