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Internationalization of Traditional/Complementary Medicine products: market entry as medicine
Li, Jiatong1; Zhu, Jianfan1; Hu, Hao1; Harnett, Joanna E.2; Lei, Chi Ieong3; Chau, Ka Yin4; Chan, Ging1; Ung, Carolina Oi Lam1,2,3
Source PublicationCHINESE 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 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.

KeywordTraditional Chinese Medicines Chinese Patent Medicines Proprietary Chinese Medicines Traditional And Complementary Medicine Registration Internationalization Quality Safety Efficacy
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Indexed BySCIE
WOS Research AreaIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS SubjectIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS IDWOS:000447277200001
The Source to ArticleWOS
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Cited Times [WOS]:17   [WOS Record]     [Related Records in WOS]
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Affiliation1.Univ Macau, Inst Chinese Med Sci, State Key Lab Qual Res Chinese Med, Taipa, Macao, Peoples R China
2.Univ Sydney, Fac Med & Hlth, Sch Pharm, Sydney, NSW, Australia
3.Pharmaceut Soc Macau, Taipa, Macau, Peoples R China
4.City Univ Macau, Taipa, Macau, Peoples R China
First Author AffilicationUniversity of Macau
Recommended Citation
GB/T 7714
Li, Jiatong,Zhu, Jianfan,Hu, Hao,et al. Internationalization of Traditional/Complementary Medicine products: market entry as medicine[J]. CHINESE MEDICINE,2018,13.
APA Li, Jiatong,Zhu, Jianfan,Hu, Hao,Harnett, Joanna E.,Lei, Chi Ieong,Chau, Ka Yin,Chan, Ging,&Ung, Carolina Oi Lam.(2018).Internationalization of Traditional/Complementary Medicine products: market entry as medicine.CHINESE MEDICINE,13.
MLA Li, Jiatong,et al."Internationalization of Traditional/Complementary Medicine products: market entry as medicine".CHINESE MEDICINE 13(2018).
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