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.
Highlights
Chinese herbal medicines (CHMs) are defined as Chinese herbal drugs, Chinese herbal drug extracts, Chinese herbal medicinal products and traditional Chinese medicine granules (TCM granules) in this review
The quality requirements of CHMs play a critical role in the internationalization of TCM
The pharmacopoeias of some countries have established basic requirements for the quality control of CHMs, which have become the threshold for the market access of CHMs in these countries
Summary
Chinese herbal medicines (CHMs) are defined as Chinese herbal drugs, Chinese herbal drug extracts, Chinese herbal medicinal products and traditional Chinese medicine granules (TCM granules) in this review. In Europe, since 2009, Chinese herbal drug quality monographs have been gradually established and elaborated by the TCM working party in the European pharmacopoeia (Ph. Eur.) [4]. The EDQM develops the Ph. Eur., which covers the quality requirements for a wide range of substances, including herbal drugs and extracts.
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