Guidelines on adverse drug reaction reporting

It is very important to collect and to evaluate the safety information from clinical development. Any serious and unexpected adverse drug reactions should be reported with all data elements necessary for assessment of the adverse event and the causality. The Korea Food and Drug Administration (KFDA) assigned the working group that consists of representatives from academia, pharmaceutical industry and health authorities to establish clinical trial evaluation guidelines on adverse drug reaction reporting that share standards with international guidelines but are practical. The guidelines were drafted based on ICH guidelines and include definitions and standards for adverse drug reaction reporting and data elements for individual case safety reports. The draft has been presented to KFDA for their review.