Assessment of the regulatory implementation of NAMs: obstacles and opportunities
Objectives
WP3 aims to support the effective integration of New Approach Methodologies (NAMs) into EU regulatory frameworks by addressing the scientific, regulatory, and socio-economic dimensions associated with their implementation. The work is carried out in close collaboration with other NAMWISE work packages, ensuring alignment and integration of project-wide knowledge and outputs. Its core objective is to identify drivers, barriers, and gaps to recommend solutions that facilitate the regulatory uptake of NAMs, thereby promoting their application in chemical and pharmaceutical safety assessment.
Perform systematic identification and analysis of factors driving or hindering NAM implementation across EU regulatory frameworks.
Carry out a literature-based review to distil and contrast evidence on scientific uncertainties associated with traditional animal testing and NAMs
Identify commonalities and differences across EU regulations for hazard identification and characterisation to clarify opportunities and challenges for NAM adoption.
Assess the economic implications of NAM-based regulatory assessments.
Through these activities, WP3 ensures that NAMWISE not only advances scientific understanding, but also provides practical insights and strategic guidance to accelerate the regulatory acceptance and societal uptake of NAMs, supporting safer, sustainable, and ethically sound solutions for chemical and pharmaceutical safety assessment.
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Key activities
WP3 overarching objective is to provide a comprehensive understanding of the scientific, regulatory, and economic factors that can influence NAM adoption.
Through these activities, WP3 supports NAMWISE in providing regulatory, scientific, and socio-economic guidance, aiming to increase the adoption of NAMs across EU regulatory frameworks.
The work is structured into four core tasks:
Task 3.1 –
Analysis of NAM implementation in regulations: success and failures:
This task investigates the factors underlying the successes and failures of NAM regulatory implementation. The identified patterns were analysed to highlight obstacles and opportunities for advancing the uptake of NAMs for regulatory purposes.
Task 3.2 –
Comparing NAM to animal testing for regulatory use: scientific shortcomings and advantages:
This task evaluates the uncertainties associated with traditional animal models for safety assessment and contrasts them with NAM-specific uncertainties. It will be evaluated how NAMs could overcome the limitations of animal testing and contribute to an increased confidence in the use of NAMs for regulatory decision-making.
Task 3.3 –
Identification of commonalities and differences across regulatory frameworks:
This task investigates requirements for hazard identification and characterization across EU regulatory frameworks, highlighting conceptual shifts that facilitate broader adoption of NAM-based assessments and clarifying the types of information that NAMs must provide to support decision-making in diverse regulatory contexts.
Task 3.4 –
Assessment of the economic implications of moving away from animal-based to NAM-based assessments.:
This task evaluates the socio-economic costs and benefits of moving from animal-based to NAM-based assessments, compared against a Business-As-Usual (BAU) scenario.
Partners involved
Institute for Evidence-Based Toxicology (IEBT) – Lead Beneficiary
WP3 Coordinator
aquatox
Provides expert input for Task 3.1.
Austrian Institute of Technology (AIT)
Provides expert input for Task 3.2.
CHARLES RIVER LABORATORIES
Provides expert input for Tasks 3.1, 3.2, and 3.4.
INERIS
Provides expert input and for Tasks 3.1, 3.2, and 3.3, and serves as the lead beneficiary of task 3.4.
ISCIII
Serves as the lead beneficiary of Task 3.3
SANOFI-AVENTIS
Provides expert input and for task 3.1 and 3.2.
Deliverables
upcoming
Latest News & Updates
Deliverable D3.1 has been submitted following a thorough review by experts from the University of Birmingham (UoB), INERIS, ISCIII, aQuaTox Solutions, and the OECD. The results of this work will be presented at the upcoming conferences 3R-Länd in Tübingen, Germany, and ESTIV in Maastricht, The Netherlands.