Dr Li Li Zhao, China

Traditional Chinese Medicines (TCMs) have been used by the Chinese people for more than 4000 years. They have become a ‘treasure-chest’ for the prevention and treatment of disease in China. Under the Drug Law, TCMs are defined as medicines and are therefore regulated as medicines. The main task of drug regulatory authorities in the regulation of TCMs is to ensure their safety, efficacy and quality. Our evaluation of efficacy and safety of existing TCMs is based upon clinical observation and a history of their traditional use over many centuries.

For new TCMs, however, we require clinical studies adapted to TCM theory which also refer to modern medical science; for safety, we need pre-clinical studies. During the 1980s, advances in science and technology and analytical methodology for natural products, and progress of pharmacological study on TCMs, allowed deeper evaluation of the quality of TCMs. The National Institute, in collaboration with local institutions, was better able to clarify many TCMs and evaluate their quality. The abundant data obtained from such studies has contributed to the establishment of standards and specifications for TCMs.

Standardization of TCMs is an integral part of the entire quality control process. Since 1963, TCMs have been included in Volume One of the Chinese Pharmacopoeia. and the current edition lists 920. To avoid inconsistency, we have consolidated, revised and harmonized local standards, and established 4000 national standards for finished products based on previous provincial standards. In addition, to better protect the health of ethnic minorities, approximately 730 commonly-used specifications have been published.

In recent years, the safety issue of heavy metal and pesticide residues has been a concern. Some research projects have been conducted in connection with methods of control and setting of limits. Currently, our testing focuses primarily upon small molecular compounds such as alkaloids, flavonoids (Flavone), and saponin. Further research on polysaccharides, proteins, polypeptides and nucleotides is needed.

Our future goals include conducting research on quality control methods for TCMs and developing techniques of extraction, separation and purification of natural compounds, in order to meet the need for continued improvement of specifications and testing methodologies. We intend to establish standardized fingerprinting and develop more assays for single ingredients. The relationship between ingredients and clinical effects is also important.