China’s National Medical Products Administration published revised Good Clinical Practice regulations that take effect in September, introducing updated rules on clinical data governance and compliance with international ethical principles. The guidance is the first GCP update since 2020 and targets “quality management” for drug clinical trials. NMPA’s revisions include new expectations for how study information is stored and handled, emphasizing transparent recording and traceability for both paper and electronic materials. The rules also highlight participant privacy protections aligned with China’s personal information protection requirements. Sponsors, CROs, and research sites operating in China will need to review data collection, management, and analysis processes to ensure they match the intended purposes and risk level of the trials.