International expert consensus on clinical application of traditional Chinese medicine formula granules

Guided by the theory of traditional Chinese medicine (TCM), TCM formula granules are made through the optimal process of extraction, concentration, drying, and granulation by combining modern new preparation technologies and pharmaceutical technologies. TCM formula granules are stable, safe, convenient, and effective. Compared with TCM decoction pieces, TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials, processing of decoction pieces, processing technology, quality inspection, sales, and products distribution. TCM formula granules can partially replace Chinese patent medicines. Only available for around 800 common varieties of TCM, TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice. A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces. How to improve the production process, establish the quality standard, perfect the regulatory system, and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.