Background <p>The integration of artificial intelligence (AI) into traditional Chinese medicine (TCM) research and development offers promising solutions to longstanding challenges in the field. These challenges include the complexity of TCM formulations, variability in quality control, and hurdles in global market acceptance. The unique synergy between AI technologies and TCM principles creates opportunities to enhance research efficiency, standardization, and innovation.</p> Aim of review <p>This review aims to explore the applications and impact of AI across three critical stages of TCM development: drug design, pharmaceutical manufacturing, and market access. By summarizing the advancements and limitations in these areas, the review identifies the transformative potential of AI and proposes future directions for integrating AI with emerging technologies to advance TCM research and development (R&amp;D).</p> Key scientific concepts of review <p>AI has transformative potential in TCM development, addressing key challenges across various stages. In drug design, AI accelerates the identification of active compounds, optimizes formula composition, and models pharmacodynamic relationships to enhance innovation efficiency and precision. During pharmaceutical manufacturing, AI contributes to process optimization, quality control, and the standardization of TCM products, ensuring stable and scalable production. For market access, although no TCM developed by AI has entered the clinic, AI has played a role in comprehensive safety and efficacy assessments and simplified regulatory compliance in other drugs. By leveraging these advances and reviewing limitations, AI promotes the need to develop more integrated, more efficient, </p> <p>and more utilized methods in TCM R&amp;D.</p>