China’s National Medical Products Administration (NMPA) has issued updated Good Clinical Practice (GCP) regulations that take effect in September, tightening requirements around data governance, privacy, and ethical compliance. The update is the first since 2020 and emphasizes transparent, traceable handling of both paper and electronic clinical trial materials. The revised guideline instructs trial sponsors, CROs, and sites to store and process study data to support reliability and traceability while protecting participants’ personal information in line with China’s personal information protection laws. It also reiterates international ethical anchors, including principles from the Declaration of Helsinki. Separately, the Association of Clinical Research Organizations (ACRO) is urging the FDA to include CROs as direct participants in a proposed AI trial pilot, rather than treating them as subcontractors. ACRO argues CROs have a global line of sight into real-world trial operations and can help regulators balance patient safety, data integrity, and evidentiary standards. Taken together, the moves signal tighter expectations on clinical trial data handling—while also pushing for clearer stakeholder roles as real-time and AI-enabled trial designs expand.