China’s National Medical Products Administration (NMPA) has published the draft Good Clinical Practice for Drugs (2025) with fundamental changes to further enhance participant protection, data integrity, and trial quality. Published at the end of October, 2025, this draft condenses the current eight-chapter GCP regulations into six chapters, introduces a new section on Data Governance, and names the sponsor as the ultimately responsible entity. It also defines the Principal Investigator (PI) as the site-level responsible person. Comments are open to the public until the end of November.
The proposed changes reflect China’s further step toward international harmonization, risk-based oversight, including concepts like Quality by Design (QbD), fit-for-purpose trial design, and proportionate risk management. The draft reinforces GCP enforcement from a legal perspective by incorporating the Measures for the Administration of Drug Registration.
Key changes include compulsory annual ethics reviews; the extension of protection for vulnerable subjects; and additional stringency in investigational product management, including the retention of bioequivalence (BE) samples for two years. A new data governance chapter introduces standards on data integrity, such as the validation of systems and audit trails, metadata, confirmation of datasets, etc.
For sponsors and CROs, the draft signals higher expectations regarding risk management, electronic system validation, and liability coverage, while oversight of clinical operations and outsourcing will be significantly more rigorous. Sponsors operating in China are encouraged to begin gap assessments and internal quality system updates now to prepare for the finalization of the GCP revision.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.