NAM Journal Paper - “Panel discussions on the global regulatory acceptance and harmonization of non-animal NAMs”

I had the privilege of co-authoring a paper titled “Panel discussions on the global regulatory acceptance and harmonization of non-animal NAMs” published in the NAM Journal (volume 1, 2025, 100027).  The paper provides a comprehensive overview of two panel discussions held as webinars that delve into the challenges and opportunities associated with the global regulatory acceptance of NAMs, aiming to reduce or replace animal testing.  The discussions, hosted by the scientific committee Pro Anima, centered on regulatory challenges, the importance of stakeholder engagement, validation obstacles, and coordinated international efforts aimed at accelerating the broader and more effective adoption of NAMs in safety decision-making. It also explored the growing role of emerging technologies, including artificial intelligence (AI), in advancing NAMs and highlighted successful case studies, ongoing initiatives, existing challenges, and opportunities.

Key Takeaways from the Panel Discussions

• Global Perspectives on NAMs: The panels highlighted the varying degrees of acceptance and implementation of NAMs across different regulatory bodies worldwide. While some regions have made significant strides, others are still in the nascent stages of integrating these methodologies into their regulatory frameworks.

• Challenges in Harmonization: One of the primary challenges discussed was the lack of harmonization in regulatory requirements, which can hinder the global adoption of NAMs. Differences in validation processes, data interpretation, and acceptance criteria were identified as barriers that require attention.

• Opportunities for Collaboration: The discussions underscored the importance of collaborative efforts among stakeholders, including regulatory agencies, industry, and academia, to facilitate the development and acceptance of NAMs. Sharing data, best practices, and aligning on validation standards were proposed as steps toward achieving global harmonization.

The transition toward NAMs represents a significant evolution in toxicological assessments, promising more ethical, efficient, and potentially more predictive approaches.  The insights from these panel discussions inform strategic decisions and foster collaborations that drive the adoption of innovative, non-animal testing methods.  Realizing the full potential of NAMs in regulatory science requires concerted efforts to overcome existing challenges by engaging in dialogues, such as the ones highlighted in this NAM Journal article, and participating in collaborative initiatives.  Based on the outcomes of these two discussions, Pro Anima will continue dialogue around innovative approaches to support NAMs development and implementation through additional panel series discussions in 2026. 

Access the full paper here