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Key quality factors for Chinese herbal medicines entering the EU market
Mei Wang1,3; Pei-Fen Yao2; Peng-Yue Sun3; Wen Liang3; Xiao-Jia Chen2,4
2022-02-22
Source PublicationChinese Medicine
ISSN1749-8546
Volume17Pages:29
Abstract

Chinese herbal medicines (CHMs) have unique advantages in the prevention and treatment of diseases, which are widely recognized in the world. More and more CHMs are becoming increasingly popular in the international markets. However, the quality control of CHMs is a significant issue for their acceptance and recognition in the international market. This review mainly focuses on the quality requirements for CHMs to enter the European Union (EU) market. Both Chinese and European regulations and quality controls are compared. Firstly, the EU medicinal regulatory system and relevant regulations were reviewed. Secondly, the key factors of the quality control of CHMs, including Chinese herbal drugs, extracts and products were compared with those of European herbal medicines in the EU market. Subsequently, three main registration routes for herbal medicinal products including Chinese herbal medicinal products entering the EU were introduced. Furthermore, the legal status of traditional Chinese medicine granules in the EU was also discussed. Through the comparison of the key quality factors for CHMs in China and the EU, the similarities and differences in terms of quality requirements and regulations are addressed, which provides a reference for the development of CHMs into the EU market.

KeywordChinese Herbal Medicines Chinese Pharmacopoeia European Herbal Medicine Legislation European Market European Pharmacopoeia Quality Requirements
DOI10.1186/s13020-022-00583-x
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS SubjectIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS IDWOS:000759593400003
PublisherBMC, CAMPUS, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
Scopus ID2-s2.0-85125442424
Fulltext Access
Citation statistics
Document TypeJournal article
CollectionTHE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU)
Institute of Chinese Medical Sciences
Corresponding AuthorMei Wang; Xiao-Jia Chen
Affiliation1.LU-European Center for Chinese Medicine and Natural Compounds, Institute of Biology, Leiden University, Leiden, Sylviusweg72, 2333BE, Netherlands
2.Institute of Chinese Medical Sciences, and State Key Laboratory of Quality Research in Chinese Medicine, University of Macau, Avenida da Universidade, Taipa, Macao
3.SU Biomedicine, Leiden, BioPartner Center 3, Galileiweg 8, Leiden Bio Science Park, 2333 BD, Netherlands
4.Zhuhai UM Science & Technology Research Institute, Zhuhai, 519031, China
Corresponding Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
GB/T 7714
Mei Wang,Pei-Fen Yao,Peng-Yue Sun,et al. Key quality factors for Chinese herbal medicines entering the EU market[J]. Chinese Medicine, 2022, 17, 29.
APA Mei Wang., Pei-Fen Yao., Peng-Yue Sun., Wen Liang., & Xiao-Jia Chen (2022). Key quality factors for Chinese herbal medicines entering the EU market. Chinese Medicine, 17, 29.
MLA Mei Wang,et al."Key quality factors for Chinese herbal medicines entering the EU market".Chinese Medicine 17(2022):29.
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