China’s NMPA has issued new measures strengthening oversight of entrusted drug manufacturing, reinforcing the responsibilities of both Marketing Authorization Holders and contract manufacturers. The framework emphasizes GMP compliance, quality management, traceability, and lifecycle risk control, while introducing enhanced requirements for technical transfer, change management, audits, and pharmacovigilance. The measures also establish stricter conditions for certain manufacturing licenses and expand the use of risk-based inspections. Overall, the reforms support greater regulatory accountability, digitalization of quality systems, and the continued development of China’s CDMO sector.