Clinical trials of drugs, drug therapies, vaccines, and diagnostic procedures in China will for the first time be aligned with internationally accepted regulatory practices under standards which went into effect July 1.
The standards, under development for some time and first released in April by the National Medical Products Administration’s Center for Drug Evaluation (CDE), synchronize China’s regulatory approach with Good Clinical Practices, the international standard of conducting clinical trials.
The new standards clarify sponsor and investigator reporting responsibilities for the conduct of research studies in human beings used to determine whether new drugs, diagnostics, or treatments are safe and effective. They mandate annual safety updates during clinical trials and timely reporting of serious and other adverse events and potential safety risks. Chinese health officials say the revised standards are designed to deepen ongoing reforms of the country’s drug review and approval system, promote research, and encourage innovation.