亚洲社会药学

Objective To better understand the quality risks in non-clinical tests of traditional Chinese medicines (TCMs) and natural medicines (NMs), and to provide suggestions and reference for improving the quality of TCMs and NMs in both non-clinical tests and successful marketing. Methods According to the “Good Laboratory Practice (GLP)” “Provisions of Drug Registration” “Requirements for the Classification and Application of Traditional Chinese Medicine Registration” “Technical Requirements for the Research of New Natural Drugs” and the “Quality Management Standards to Produce Chinese Medicinal Materials”, etc., the quality risks of TCMs and NMs in non-clinical tests were analyzed. Results and Conclusion In the non-clinical trial stage of traditional Chinese medicines and NMs, the quality risks for pharmaceutical companies came from the sources of herbs and simple quality identification method of active ingredients. Clinical research organization (CRO) had many experimental personnel that caused the uneven experimental level. Besides, due to the poor standardization of pharmacodynamic experiments in research institutes of universities, the original records were imperfect, and the experience in exploring drug safety experiments was insufficient. Therefore, quality risks in non-clinical tests of TCMs and NMs should be controlled. Pharmaceutical companies should be the main body of research and development of TCMs and NMs. However, research institutes of universities and CRO companies can provide corresponding technical support to jointly promote the development of non-clinical tests of TCMs and NMs.