ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology

The U.S. Food and Drug Administration (FDA), in collaboration with the Health and Environmental Sciences Institute (HESI) and the Safety Pharmacology Society (SPS), will host a hybrid public workshop titled “ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology” on July 28, 2026. This one-day event will bring together representatives from regulatory agencies and industry to discuss potential revisions to the International Council for Harmonisation (ICH) S7A guideline. The workshop is intended to gather stakeholder perspectives, explore scientific considerations, and support the development of a cohesive framework for integrating new approach methodologies (NAMs) into safety pharmacology.

The meeting will focus on sharing real-world experiences and fostering dialogue around the application of NAMs, including their benefits, limitations, and implementation timelines. Discussions will also address the evolving regulatory landscape, particularly efforts to reduce reliance on animal testing and evaluate alternative models.

Workshop objectives:

• Establish a shared, cross-regional understanding of NAMs in safety pharmacology
• Clarify regulatory opportunities and constraints for NAM inclusion in S7A
• Define clear, discipline-specific NAM use cases relevant to S7A
• Develop actionable recommendations and next steps to support NAM integration into S7A

While the workshop will not result in immediate changes to regulatory guidance, insights generated during the event are expected to inform future policy considerations and contribute to the advancement of safety evaluation practices.

This event will be held both in-person and online.

Visit the event page for more information.