From "wish-list" to successful delivery: Opportunities for multidisciplinary and multisectoral engagement in implementation of strategies to phase out animal testing.

Abstract

Regulatory agencies worldwide are calling for New Approach Methods (NAMs) that reduce reliance on vertebrate animal testing in toxicological risk assessment and related regulatory decision-making. In this Brief Communication, we consider three recent examples of holistic strategies that support the development, validation, and uptake of NAMs in regulatory settings, namely the 'Strategy to replace, reduce or refine vertebrate animal testing under the Canadian Environmental Protection Act, 1999 (CEPA)', the 'Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods' in the United Kingdom, and the 'Roadmap towards phasing out animal testing for chemical safety assessments' from the European Union. The development, consultation on, and publication of these strategies represent an important step forward in the regulatory adoption of NAMs. We aim to interpret and highlight commonalities and differences between these strategies to identify the themes and actions being proposed to eliminate NAM obstacles and enhance NAM drivers in different regulatory settings. Further, we consider some of the challenges that may lay ahead in the effective implementation and delivery of these strategies, including 1) Sustaining commitment to delivery of aspirational plans, 2) Increasing engagement in regulatory processes by NAM developers, and 3) Increasing the regulatory relevance of NAM data.