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Internationalization of Traditional/Complementary Medicine products: market entry as medicine

Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for traditional Chinese medicines (TCMs), the global market continues to expand due to an interest in the potential clinical benefits of...

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Autores principales: Li, Jiatong, Zhu, Jianfan, Hu, Hao, Harnett, Joanna E., Lei, Chi Ieong, Chau, Ka Yin, Chan, Ging, Ung, Carolina Oi Lam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182808/
https://www.ncbi.nlm.nih.gov/pubmed/30337951
http://dx.doi.org/10.1186/s13020-018-0209-6
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author Li, Jiatong
Zhu, Jianfan
Hu, Hao
Harnett, Joanna E.
Lei, Chi Ieong
Chau, Ka Yin
Chan, Ging
Ung, Carolina Oi Lam
author_facet Li, Jiatong
Zhu, Jianfan
Hu, Hao
Harnett, Joanna E.
Lei, Chi Ieong
Chau, Ka Yin
Chan, Ging
Ung, Carolina Oi Lam
author_sort Li, Jiatong
collection PubMed
description Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for traditional Chinese medicines (TCMs), the global market continues to expand due to an interest in the potential clinical benefits of traditional approaches that are largely considered lower risk and lower cost than many conventional treatments. While the benefits of internationalization hold clear advantages for the business of T&CM products, keeping abreast of regulatory processes in different countries and regions that regularly revise market entry requirements is challenging. At present, the regulations of T&CM products are country specific and largely based on a risk-based assessment with a focus on protecting the consumer. To date, systematic analysis of these regulatory differences between countries and regions is limited. Publically available information about the legal requirements for the market entry of T&CM products were obtained from the relevant regulatory authority’s websites for selected countries and regions (Macau-China, Hong Kong-China, Singapore, Australia, Canada, the European countries and the US). The market entry requirements in terms of quality, safety and efficacy of T&CM products for each country were analyzed and compared. Major differences were identified in the classification of T&CM products, market entry pathways, requirements of compliance with Good Manufacturing Practices; and level of evidence to demonstrate safety and efficacy based on historical use, non-clinical and clinical studies. Variations in the evaluation standards adopted by regulatory authorities pose a number of barriers and opportunities for the internationalization of T&CM products and have great implications for internationalization of TCMs from the sponsors’ and the regulators’ perspectives.
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spelling pubmed-61828082018-10-18 Internationalization of Traditional/Complementary Medicine products: market entry as medicine Li, Jiatong Zhu, Jianfan Hu, Hao Harnett, Joanna E. Lei, Chi Ieong Chau, Ka Yin Chan, Ging Ung, Carolina Oi Lam Chin Med Review Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for traditional Chinese medicines (TCMs), the global market continues to expand due to an interest in the potential clinical benefits of traditional approaches that are largely considered lower risk and lower cost than many conventional treatments. While the benefits of internationalization hold clear advantages for the business of T&CM products, keeping abreast of regulatory processes in different countries and regions that regularly revise market entry requirements is challenging. At present, the regulations of T&CM products are country specific and largely based on a risk-based assessment with a focus on protecting the consumer. To date, systematic analysis of these regulatory differences between countries and regions is limited. Publically available information about the legal requirements for the market entry of T&CM products were obtained from the relevant regulatory authority’s websites for selected countries and regions (Macau-China, Hong Kong-China, Singapore, Australia, Canada, the European countries and the US). The market entry requirements in terms of quality, safety and efficacy of T&CM products for each country were analyzed and compared. Major differences were identified in the classification of T&CM products, market entry pathways, requirements of compliance with Good Manufacturing Practices; and level of evidence to demonstrate safety and efficacy based on historical use, non-clinical and clinical studies. Variations in the evaluation standards adopted by regulatory authorities pose a number of barriers and opportunities for the internationalization of T&CM products and have great implications for internationalization of TCMs from the sponsors’ and the regulators’ perspectives. BioMed Central 2018-10-11 /pmc/articles/PMC6182808/ /pubmed/30337951 http://dx.doi.org/10.1186/s13020-018-0209-6 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Review
Li, Jiatong
Zhu, Jianfan
Hu, Hao
Harnett, Joanna E.
Lei, Chi Ieong
Chau, Ka Yin
Chan, Ging
Ung, Carolina Oi Lam
Internationalization of Traditional/Complementary Medicine products: market entry as medicine
title Internationalization of Traditional/Complementary Medicine products: market entry as medicine
title_full Internationalization of Traditional/Complementary Medicine products: market entry as medicine
title_fullStr Internationalization of Traditional/Complementary Medicine products: market entry as medicine
title_full_unstemmed Internationalization of Traditional/Complementary Medicine products: market entry as medicine
title_short Internationalization of Traditional/Complementary Medicine products: market entry as medicine
title_sort internationalization of traditional/complementary medicine products: market entry as medicine
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182808/
https://www.ncbi.nlm.nih.gov/pubmed/30337951
http://dx.doi.org/10.1186/s13020-018-0209-6
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