Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”
On July 10, 2023, China’s Center for Drug Evaluation released a draft guidance for a two-week comment period titled, “Safety Information Assessment and Risk Management Work Procedures.” It outlines the agency’s expectations for the monitoring, identification, evaluation, control, and communication of safety risks during clinical trials conducted in China. According to the public notice, the […]