Abstract
The ICH S7A guideline on safety pharmacology has remained unchanged since its inception in 2000, fulfilling its crucial role in safeguarding clinical trial participants and patients (ICH S7A). However, in the meanwhile there has been significant scientific and technological advancements in drug safety science, a paradigm shifts of the drug discovery and development process, and an continuously evolving regulatory landscape, that led to the recommendation to revisit, adapt and evolve the ICH S7A guideline (Valentin & Leishman, 2023, 2025). A revision of the guidance would imply opening an ICH process, the first step consists in the development of a 'concept paper'. In that context, a survey has been developed to determine which elements, if any, of the ICH S7A guideline should be revised. Sixty-five (65) responses were obtained from industry representatives of companies affiliated to EFPIA, JPMA or PhRMA. Overall, there was a large support to revisit most of the pillars originally identified via a 'revision' or a 'Q&As' ICH procedure. These include revisiting the 'core battery' assessment (58 to 68 %), the adversity concept (77 %), the modality agnosticism of the guideline (89 %), the in vitro secondary pharmacology component (85 %), the integrated risk assessment principles (75 %), and the inclusion of safety pharmacology endpoints in general toxicology studies (72 %). However, there were fewer than 50 % positive responses to revisiting the timing of the studies with respect to drug development stages and the validation or qualification principles to be applied to novel assays and models (<50 % of positive responses). Notably, the majority of respondents viewed the 'core battery' studies as valuable, whereas 'supplemental' studies were less frequently seen as contributing additional value. Moreover, many indicated that they routinely perform safety pharmacology studies outside of these predefined categories-such as exploratory, mechanistic, or investigative studies.. Overall, there was a large agreement between the responses from all territories. The survey results captured which elements of the ICH S7A guideline should be revised to help the development of a formal ICH concept paper.
