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核心技术专利:CN118964589B侵权必究
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Internationalization of Traditional/Complementary Medicine products: market entry as medicine.

作者信息

Li Jiatong, Zhu Jianfan, Hu Hao, Harnett Joanna E, Lei Chi Ieong, Chau Ka Yin, Chan Ging, Ung Carolina Oi Lam

机构信息

1State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Taipa, Macao.

2The University of Sydney School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

出版信息

Chin Med. 2018 Oct 11;13:50. doi: 10.1186/s13020-018-0209-6. eCollection 2018.


DOI:10.1186/s13020-018-0209-6
PMID:30337951
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6182808/
Abstract

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.

摘要

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本文引用的文献

[1]
International Comparison of Five Herbal Medicine Registration Systems to Inform Regulation Development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain.

Pharmaceut Med. 2018

[2]
Internationalization of traditional Chinese medicine: current international market, internationalization challenges and prospective suggestions.

Chin Med. 2018-2-9

[3]
Regulation of proprietary traditional Chinese medicines in Australia.

Chin J Nat Med. 2017-1

[4]
How do government regulations influence the ability to practice Chinese herbal medicine in western countries.

J Ethnopharmacol. 2016-12-1

[5]
TradReg 2013: regulation of herbal and traditional medicinal products--European and global strategies--international symposium.

J Ethnopharmacol. 2014-12-2

[6]
Future visions for traditional and herbal medicinal products--a global practice for evaluation and regulation?

J Ethnopharmacol. 2014-12-2

[7]
The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

J Ethnopharmacol. 2014-12-2

[8]
Traditional herbal medicines worldwide, from reappraisal to assessment in Europe.

J Ethnopharmacol. 2014-12-2

[9]
TCM-based new drug discovery and development in China.

Chin J Nat Med. 2014-4

[10]
Legal status and regulation of complementary and alternative medicine in Europe.

Forsch Komplementmed. 2012

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