Workshop on the Revision of ICH S7A

HESI Global recently co-hosted a workshop focused on Aligning Regulatory and Industry Perspectives on the Revision of ICH S7A, alongside the Animal-Free Safety Assessment Collaboration and Humane World for Animals. This workshop brought together regulatory and industry stakeholders for a three-day hybrid event to discuss and build consensus around a potential revision of the ICH S7A guidelines. There was strong, unanimous agreement on the need to revise S7A, with a shift away from mandatory tests toward a weight-of-evidence approach.

Industry and regulatory colleagues will take the lead on specific next steps related to the ICH process for topic proposals and guideline revision. HESI Global will continue to play a supporting role by building awareness and consensus across a broader stakeholder group. This includes helping to convene additional workshops and webinars, as well as present posters or symposia at international scientific conferences.

HESI Global will also coordinate efforts to address gaps identified at the workshop, including defining the weight-of-evidence framework, clarifying the role of secondary pharmacology, and defining adversity as it relates to S7A. If you are interested in learning more, please reach out to Jennifer Pierson (jpierson@hesiglobal.org.)