The medical products administration bureaus of Beijing, Tianjin, and Hebei province have released a draft proposal for the “Supervision and Inspection Standards for Clinical Trial Institutions of Drugs in the Beijing Tianjin Hebei Region (2024 Edition)” and are soliciting public feedback from February 8 to March 8, 2024.
The 2024 Inspection Standards represent an evolution from the 2021 version, streamlining the structure from three parts—covering drug clinical trial organization and management, ethics committee, and profession—into two parts: institution and profession. Notably, the ethics committee is now included within the institution inspection module. The 2024 standards have also refined the inspection items and defect levels, expanding from two levels—critical and general items—to three levels: critical items, main items, and general items. Defects identified during inspections have been reclassified from two levels—severe defects and general defects—to three levels: severe defects, major defects, and general defects. Additional adjustments and updates have been made to relevant inspection processes and items, including the addition of “project initiation and completion management” inspections.
The 2024 Inspection Standards encompass 19 inspection steps and 148 inspection items, which include on-site inspections of qualification conditions, filing, and operation management. The inspection project features a total of 14 key items, comprising 60 main items and 74 general items.- Flcube.com
