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Key quality factors for Chinese herbal medicines entering the EU market

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 accep...

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Autores principales: Wang, Mei, Yao, Pei-Fen, Sun, Peng-Yue, Liang, Wen, Chen, Xiao-Jia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8861989/
https://www.ncbi.nlm.nih.gov/pubmed/35193628
http://dx.doi.org/10.1186/s13020-022-00583-x
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author Wang, Mei
Yao, Pei-Fen
Sun, Peng-Yue
Liang, Wen
Chen, Xiao-Jia
author_facet Wang, Mei
Yao, Pei-Fen
Sun, Peng-Yue
Liang, Wen
Chen, Xiao-Jia
author_sort Wang, Mei
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13020-022-00583-x.
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spelling pubmed-88619892022-02-22 Key quality factors for Chinese herbal medicines entering the EU market Wang, Mei Yao, Pei-Fen Sun, Peng-Yue Liang, Wen Chen, Xiao-Jia Chin Med Review 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13020-022-00583-x. BioMed Central 2022-02-22 /pmc/articles/PMC8861989/ /pubmed/35193628 http://dx.doi.org/10.1186/s13020-022-00583-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Review
Wang, Mei
Yao, Pei-Fen
Sun, Peng-Yue
Liang, Wen
Chen, Xiao-Jia
Key quality factors for Chinese herbal medicines entering the EU market
title Key quality factors for Chinese herbal medicines entering the EU market
title_full Key quality factors for Chinese herbal medicines entering the EU market
title_fullStr Key quality factors for Chinese herbal medicines entering the EU market
title_full_unstemmed Key quality factors for Chinese herbal medicines entering the EU market
title_short Key quality factors for Chinese herbal medicines entering the EU market
title_sort key quality factors for chinese herbal medicines entering the eu market
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8861989/
https://www.ncbi.nlm.nih.gov/pubmed/35193628
http://dx.doi.org/10.1186/s13020-022-00583-x
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