This section provides a comprehensive overview of the safety data from clinical studies, focusing on the nature and frequency of adverse events, safety in specific population subsets, and any identified risks associated with the medicinal product. This section includes an analysis of the overall safety profile, highlighting critical safety findings, dose-related effects, and any significant safety concerns that arose during the clinical development program. It also discusses the methodologies used to evaluate safety, such as monitoring protocols and data analysis strategies.

Read the ICH guidance here.