Revisiting ICH S7A after 25 years: Outcomes of a multi-stakeholder workshop and strategic pillars for modernizing safety pharmacology

HESI Global is pleased to share a new publication, “Revisiting ICH S7A after 25 years: Outcomes of a multi-stakeholder workshop and strategic pillars for modernizing safety pharmacology,” published in Regulatory Toxicology and Pharmacology. The paper captures the outcomes of a February 2026 workshop that brought together stakeholders from industry, regulatory agencies, academia, and NGOs to explore priorities for modernizing the ICH S7A guideline.

This work matters because ICH S7A has remained unchanged for 25 years, even as drug development, therapeutic modalities, and new approach methodologies have advanced significantly. The publication outlines key priorities for a modernized, risk-based framework, including a stronger weight-of-evidence approach, better integration of secondary pharmacology, and clearer interpretation of functional findings such as adversity. Together, these recommendations support more flexible, human-relevant safety pharmacology while maintaining strong protection of clinical trial participants and patients.

HESI Global will continue supporting broader awareness and stakeholder dialogue as this work moves forward.

Read the full publication here: Valentin et al., 2026. Revisiting ICH S7A after 25 years: Outcomes of a multi-stakeholder workshop and strategic pillars for modernizing safety pharmacology. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2026.106096

Learn more about HESI Global’s work in this area here: https://hesiglobal.org/cardiac-safety/