In order to standardize the risk monitoring, identification, assessment, and control of safety information in pediatric drug clinical trials, the CDE, under the deployment of the NMPA, has organized the formulation of the Technical Guideline for Safety Information Assessment and Reporting in Pediatric Drug Clinical Trials (Interim). This guideline is hereby issued and shall be implemented as of the date of issuance with the approval of the NMPA and in accordance with the requirements of the Notice of the NMPA Comprehensive Department on Printing and Issuing the Release Procedures for Drug Technical Guidance (YJZYG [2020] No.9).

It is hereby notified.