Quality control system ensuring consistent efficacy for traditional Chinese medicine preparations

The essential requirements of traditional Chinese medicine (TCM) and its identity of drug make it necessary to treat TCM preparations with considerations of clinical practice routines and drug attributes. Quality stability is an elementary drug quality attribute and lays the foundation to guarantee a consistent traditional Chinese medicines (TCMs) efficacy. In light of the complex ingredients of natural sources, the unique medical theory and the safety & efficacy proof from clinical practices, it's hardly possible to objectively evaluate and effectively control TCMs quality using qualitative and quantitative methods with chemical components as references. To ensure efficacy consistency, stable TCMs quality is a prerequisite and thus is regarded as an industrial focus in earnest need of regulatory attention and also the key points and challenge of TCM quality study and assessment. Since the initiation of drug evaluation system reform, Center for Drug Evaluation has devoted to TCM regulatory science study and issued a series of guidelines. These guidelines are established based on characteristics of TCM preparations, scientific principles and actual production situations. Meanwhile, traditional thinking and experience in TCM quality control and modern theories such as "Quality by Design" and "Whole-process Quality Control" were also adopted. As the characteristics of TCM preparations and quality control requirements, this paper analyses the above guidelines, and concludes that these documents have combined TCM clinical experience and drug attributes of safety, efficacy and quality control. They provide guidance for ensuring basic stability of TCM ingredients and reducing batch-to-batch variations. A quality control system that meets the above requirements is established to ensure consistent efficacy of TCM preparations.