From Tradition to Evidence-base: Leveraging TCM Human Use Experience in Modern Drug Development

This review presents the innovative integration of Traditional Chinese Medicine (TCM) into contemporary drug development, emphasizing the strategic synthesis of millennia of TCM human use experience with modern pharmaceutical methodologies. Our exploration focuses on leveraging human clinical experiences to guide the modernization of TCM, particularly in the development of new drugs. We address the regulatory landscapes in China, the United States, and the European Union, discussing the challenges and advancements in quality control and pre-clinical research requirements that accommodate TCM practices within these regulatory frameworks. Based on extensive human experiments, we delve into the methodological challenges and innovations necessary for integrating TCM into the evidence-based medical landscape. We propose a systematic approach to collect and analyze TCM clinical data, including the establishment of a standardized TCM human use experience database. This effort aims to translate TCM concepts into modern medicinal practices, ensuring efficacy, safety, and regulatory compliance. Our findings advocate for a balanced approach that respects TCM's rich heritage while embracing contemporary scientific and clinical standards. This integration promises to enrich global healthcare with diverse, evidence-based treatment options, contributing significantly to the broader acceptance and integration of TCM in global healthcare systems.