As per NMPA CMDE Department 2, when using overseas clinical trial data for registration in China, the applicant should submit the EC opinions (such as EC approval letter) from overseas clinical trial institutions, clinical trial protocol and clinical trial report. The form, content, signature and seal of these documents shall meet the relevant requirements of clinical trial quality management in the country (region) where the overseas clinical trial is conducted. In addition, the applicant should also submit a gap analysis report on the factors related to domestic and overseas clinical trials, detailing the such gaps and the relevant treatment measures. If necessary, relevant laws, regulations, specifications or standards related to clinical trial quality management in the country (region) where the overseas clinical trial is conducted should also be submitted.
The applicant should provide complete overseas clinical trial data without screening. The overseas clinical trial report should include the analysis and conclusion of the complete clinical trial data.
