Gaining regulatory acceptance for novel technologies in nonclinical drug development: A scoping review of its conceptualization in scientific literature

Abstract

Although integrating novel technologies into nonclinical drug development can counteract declining R&D success, their path to regulatory acceptance is often unclear and uncertain as they are not subject to a single, predictable regulatory approval framework like medicinal products. Existing literature on regulatory acceptance is mostly confined to specific technologies or regulatory pathways, hindering cross-domain learning. Therefore this scoping review develops a more context-agnostic understanding of regulatory acceptance by characterizing its commonalities across a range of technological and regulatory contexts. Our analysis of 54 articles found that regulatory acceptance can take on multiple forms, shaped by a particular scope (technological, contextual, and geographical) and formation process involving a driving need, gaining regulatory confidence, and interaction between actor groups. As technological specificity increases, the nature of the aforementioned elements shifts from broad discussions of potential to formal, evidence-based procedures. Understanding acceptance as a diverse process unified by core conceptual elements, rather than a single hurdle, provides a common language that cuts across technological domains and helps contextualize future research, thereby enabling regulators and developers to better integrate novel technologies in nonclinical drug development.