China has revised its Good Clinical Practice (GCP) regulations for drug clinical trials, introducing new requirements focused on quality management, participant protection, investigator accountability, and the use of innovative technologies.
One major change is the adoption of a Quality by Design (QbD) approach. The new GCP now expects sponsors and investigators to define critical quality factors, perform risk assessments, and put in place suitable controls while planning and implementing the clinical trial.
Ethics committees will have expanded oversight responsibilities. In addition to reviewing study protocols and informed consent documents, they will now review important protocol deviations, interim progress reports, and study completion or termination reports. The revised GCP also increases accountability for principal investigators. Key trial decisions and official communications generally cannot be delegated. Principal investigators must implement corrective and preventive actions (CAPA) when protocol deviations occur and review sponsor safety updates to determine whether changes to participant management are needed.
Overall, the revised GCP adopts a more risk-based approach to clinical trial management while strengthening participant protections and supporting the use of innovative trial methods.