Comparative Regulatory Timelines: Does Early Engagement For Nams Actually Shorten Overall Preclinical Development

Abstract

New approach methodologies (NAMs), which include in vitro, in silico, and other non-animal methods of testing, are poised to revolutionize the traditional preclinical safety assessment paradigms. There has been growing support for NAMs by the regulatory authorities globally, due to ethical, scientific, and policy imperatives to reduce the use of animals in testing. Yet, all enthusiasm around the potential of NAMs notwithstanding, there lingers one crucial question: Does early regulatory engagement on NAM accelerate the preclinical development timelines? It is hoped that this review brings us to the state of existing literature and regulatory frameworks to appraise the impact of early dialogue with Regulatory agencies such as the FDA, EMA, Health Canada, and PMDA on development trajectories. The article looks at the timelines involved with traditional versus NAM-based preclinical approaches, the efficiency of early scientific advice procedures, and the obstacles to full adoption. Main focus is laid on the timing of early engagement strategies (e.g., pre-IND and Scientific Advice meetings) as potential key thinking points to reduce the overall development time and to allow NAMs to be accepted and validated earlier in the drug development process and thus streamline the regulatory submissions. The review concludes that while early engagement enhances regulatory clarity, its ability to accelerate timelines depends on key factors. These include regulatory agency familiarity with NAMs, data standardization, and the harmonization of international expectations.