9/20/2023 0 Comments Medicine export business![]() ![]() The classic dosage forms of traditional Chinese herbal medicinal products include decoction, pill, powder, concentrated decoction, ointment, plaster, syrup, wine, suppository, tincture and so on. Thus, several traditional processing methods have been developed, including cutting, crushing, steaming, calcining, and stir-frying with or without liquid/solid excipients (honey, Chinese yellow wine, Chinese vinegar, salt, soil, rice wheat bran etc.). For improving therapeutic effects and reducing toxicity, many Chinese herbal drugs need to be processed before clinical applications. TCM theories consider that CHMs have four properties, including heat, warm, cold and cool, and five flavors, including sweet, acrid, salty, sour and bitter. The use of CHMs should be under the guidance of traditional Chinese medicine (TCM) theories. 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.Ĭhinese 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. Furthermore, the legal status of traditional Chinese medicine granules in the EU was also discussed. ![]() Subsequently, three main registration routes for herbal medicinal products including Chinese herbal medicinal products entering the EU were introduced. 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. Firstly, the EU medicinal regulatory system and relevant regulations were reviewed. Both Chinese and European regulations and quality controls are compared. This review mainly focuses on the quality requirements for CHMs to enter the European Union (EU) market. However, the quality control of CHMs is a significant issue for their acceptance and recognition in the international market. More and more CHMs are becoming increasingly popular in the international markets. Chinese herbal medicines (CHMs) have unique advantages in the prevention and treatment of diseases, which are widely recognized in the world.
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