This Regulation, issued by the NMPA and relevant authorities, modernizes China’s Good Clinical Practice framework for drug clinical trials in alignment with international standards, including ICH E6 (R3). It strengthens the governance of clinical trials by clarifying the respective responsibilities of sponsors and investigators and reinforcing accountability throughout the trial lifecycle. The Regulation also embeds quality management and risk-based principles into the planning, conduct, and oversight of clinical trials, while enhancing requirements for data integrity, security, and traceability. Overall, it promotes a more transparent, efficient, and internationally harmonized regulatory framework for clinical trial conduct in China.