Bioactive assay is a method that uses biostatistics analysis and special test design to determine medicine efficacy based on biological effects and ensure quality control. The methods include potency test and bioactive limit test.

Since traditional Chinese medicines (TCMs) are numerous and various in sources of raw materials and complex in manufacturing process, it is difficult to conduct TCM quality control. Additionally, TCM comprises of multiple active ingredients with multiplex pharmacological effects, so it is impossible to ensure quality control and fully reflect clinical efficacy by only monitoring a few of chemical ingredients. Therefore, it is necessary to add bioactive assays to the current specifications to valuate TCMs comprehensively. Thus, TCM quality standards can help ensure that every batch of products are safe and effective in the clinical use.

The purpose of the Guidelines is to standardize the TCM bioactive assay studies and provide principles and requirements for test design, methodology studies, and the application of bioassays, etc.