China’s new rules for investigator-initiated trials (IITs) are expected to tighten oversight while legitimizing pathways for modalities beyond cell and gene therapies, according to reporting on State Council Order changes. The policy shift targets the “gray market” and aims to clarify regulatory expectations for IIT conduct. The shift could influence how sponsors structure early evidence generation and how CROs and academic groups engage with regulators on trial execution. For biotech firms with China development footprints, the compliance change raises planning requirements around study registration, quality governance, and trial modality fit.