Workshop Overview

The FDA, the Health and Environmental Sciences Institute (HESI), and the Society for Pharmacology and Toxicology (SPS) will conduct an open workshop on July 28, 2026, in a hybrid format. The event is organized to share the latest developments in the ICH S7A guideline and new approach methodologies. Participants can join either online or on‑site, providing high accessibility.

Why Now

Recently, technologies for new approach methods that replace animal testing and improve efficiency have advanced rapidly, prompting regulatory agencies to incorporate them. The FDA seeks to strengthen science‑based safety pharmacology assessments, providing the impetus to update the ICH S7A guideline. These changes are expected to reduce drug‑development costs and foster an ethical research environment.

Impact on Industry and Patients

Adoption of new approach methods enables more accurate and rapid toxicity predictions in the preclinical stage, potentially accelerating the transition to clinical trials. This can shorten the time for new drugs to reach the market and increase the likelihood of delivering novel therapeutic options to patients sooner. Moreover, pharmaceutical companies can meet regulatory requirements while lowering animal‑testing costs.

Anticipated Future Scenarios

If the workshop outcomes are incorporated into the ICH S7A revision, regulatory authorities worldwide are likely to adopt a harmonized standard. This would enable integrated global clinical development strategies and reduce risk associated with regional regulatory differences. Additionally, collaboration between academia and industry would be fostered, accelerating the dissemination of innovative safety pharmacology models.