Key quality factors for Chinese herbal medicines entering the EU market

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.

Crebanine induces ROS-dependent apoptosis in human hepatocellular carcinoma cells via the AKT/FoxO3a signaling pathway

“…As the FDA’s management of research and development of proprietary Chinese medicines becomes increasingly mature, more herbal medicines have been selected for clinical trials ( You et al, 2022 ). With advances in herbal medicine research, our understanding of herbal drugs is likely to grow, contributing to global acceptance and recognition of Chinese herbal medicine as is a valuable source of lead compounds for development of new drugs ( Wang et al, 2022 ). Herbal medicines may not be developed into different pharmaceutical dosage forms for the treatment of various diseases, but their bioactive derivatives can also be used as candidates for the discovery of new drugs ( Liu C. et al, 2019 ).…”

Multi-component Chinese medicine formulas for drug discovery: State of the art and future perspectives

“…The mission of the EMA is to monitor and oversee the safety and efficacy of (traditional) herbal medicines by enforcing regulations, directives, and scientific guidelines [37]. Under the EMA, development of herbal medicinal products in the European Union is systematically conducted, with an emphasis on legal safeguards and thorough ethical consideration [38]. A simplified registration procedure for (traditional) herbal medicines has been introduced in the EU to encourage benefits that outweigh risks.…”

“…Inadequate quality control is a major scientific issue preventing Chinese medicine from being modernized, because numerous factors are involved in herbal production, including the growth environment, climate, harvest season, processing methods, and storage. All these factors may result in variations in the quantities of the chemical constituents in Chinese medicines [38], thus challenging adequate assessment of the quality of Chinese medicines and the determination of quality profiles through a simple-index evaluation system. Multiple approaches should be used for the quality control and standardization of Chinese herbal medicine products, such as high-performance liquid chromatography, thinlayer chromatography, gas chromatography, capillary zone electrophoresis, and micellar electrokinetic capillary chromatography.…”