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Internationalization of traditional Chinese medicines: Market entry as MEDICINE
Li, J. T.; Zhu, J. F.; Hu, H.; Harnett, J.; Lei, C. I.; Chau, K. Y.; Ging, C.; Ung, O. L. C.
2018-09-01
Source PublicationChinese Medicine
ISSN1749-8546
Pages50-50
Abstract

Internationalization of Chinese Medicine practice and 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 for the business of TCMs hold clear advantages, the challenges of keeping abreast of regulatory processes in different countries and regions that regularly revise market entry requirements is challenging. Currently, there is no standardized international guideline for the regulation and registration of TCMs. At present, the regulations of TCMs and other traditional medicines are country specific and largely based on a risk based assessment with a focus on protecting the consumer. To date, the systematic analysis of these regulatory differences between countries and regions is limited. Publically available information about the legal requirements for the market entry of TCMs were obtained from the relevant regulatory authorities websites for 6 selected countries and regions (Macau-China, Hong Kong-China, Singapore, Australia, UK and the Netherlands). The market entry requirements for quality, safety and efficacy of traditional medicines for each country were analyzed and compared. Major differences were identified between countries for the requirements by TCMs manufacturers to comply with Good Manufacturing Practices (GMP); conduct safety assessments; provide scientific evidence from randomized clinical trials; list banned ingredients; and include only ingredients considered to be safe. The differences in the evaluation standards adopted by different regulatory authorities pose a number of barriers and opportunities for manufacturers of TCMs wanting to broaden their scope to the international market. For regulators of traditional medicines, the differences identified provide an opportunity for collaborative efforts in internationalization of the standards and processes required to provide high quality safe TCMs.

KeywordTraditional Chinese Medicines Chinese Patent Medicines Proprietary Chinese Medicines Traditional And Complementary Medicine Registration Internationalization Quality Safety Efficacy
Language英語English
The Source to ArticlePB_Publication
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Corresponding AuthorGing, C.; Ung, O. L. C.
Recommended Citation
GB/T 7714
Li, J. T.,Zhu, J. F.,Hu, H.,et al. Internationalization of traditional Chinese medicines: Market entry as MEDICINE[J]. Chinese Medicine, 2018, 50-50.
APA Li, J. T.., Zhu, J. F.., Hu, H.., Harnett, J.., Lei, C. I.., Chau, K. Y.., Ging, C.., & Ung, O. L. C. (2018). Internationalization of traditional Chinese medicines: Market entry as MEDICINE. Chinese Medicine, 50-50.
MLA Li, J. T.,et al."Internationalization of traditional Chinese medicines: Market entry as MEDICINE".Chinese Medicine (2018):50-50.
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