HESI Global Collaborative Effort to Revise ICH S7A

The International Council for Harmonization (ICH) S7A guideline on safety pharmacology studies is aimed at protecting clinical trial participants and patients. The guidelines were first published in 2000 and have not been updated in more than 25 years. In that time, science and technology has advanced as have the diversity of therapeutic modalities. Given this, there has been an increasing interest in revising the S7A guidelines. A revision requires global consensus on the need and priorities as well as harmonization across regions and sectors.

Links to relevant ICH documents are available here:
Original S7A Guidelines
Standard Operating Procedure of the ICH Working Groups

Pillars

Five key pillars have been identified as opportunities for further clarification and revision in an updated S7A. The weight of evidence (WoE) approach is foundational and the utility of safety pharmacology is based on decision-shaping evidence. The ‘context of use’ is the focused topic of the generated evidence. Ability to embrace broad spectrum of human relevant approaches from in silico, in vitro to in vivo. NAMs for safety pharmacology include: Broad secondary pharmacology assessments, Complex Humanized in vitro cell models, Augmented in vivo assessments, especially inclusion in toxicology studies. Methods can be qualified (WoE determined) against the context of use. The ultimate scheme becomes modality- and technology-agnostic.

 

Steering Team

In an effort to facilitate conversations ahead of a potential revision, HESI Global has convened a Steering Team consisting of global representatives from regulatory agencies and pharmaceutical industry. HESI Global provides a neutral forum to bring together theses groups and allow for opportunities to track ongoing activities, communications and discussion of key opportunities and gaps in the potential revision of S7A.

HESI Global is also communicating with additional stakeholder groups that represent key partners in the ecosystem to ensure consistent messaging and collection of critical feedback on a potential revision

HESI Global Staff

Committee Events

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Publications

The Journal of Pharmacological & Toxicological Methods (JPTM) is the leading international journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists and publishes focused issues that are devoted to a single research topic. A special issue focused on “Advancing Safety Pharmacology for ICH S7A(R1): From Workshop Insights to Future Frameworks” is anticipated in Fall 2026. This issue will feature manuscripts on topics related to the S7A revision and background information. It will feature articles from stakeholders in the pharmaceutical industry as well as NGOs and international regulators.

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

Valentin and Leishman, 2025. Points to consider for revising the ICH S7A guideline on safety and secondary pharmacology. Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2025.105795

Valentin et al., 2025. Results from an EFPIA, JPMA, PhRMA industry survey on reopening and revamping the ICH S7A guidance on safety and secondary pharmacology. Journal of Pharmacological and Toxicological Methods. https://doi.org/10.1016/j.vascn.2025.107763

Valentin and Leishman, 2023. 2000–2023 over two decades of ICH S7A: has the time come for a revamp? Regulatory Toxicology and Pharmacology. https://doi.org/10.1016/j.yrtph.2023.105368.

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