Accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices

ERA Action 17 in the ERA Policy Agenda (2025-2027)

Although Member States are bound by Directive 2010/63/EU that calls for the replacement of animal procedures in research, education, and regulatory testing as soon as valid alternative approaches become available, there is no coordination mechanism to ensure the development and validation of NAMs. The ERA action will actively involve all actors by setting-up an EU-wide coordination, consisting of relevant ministries, regulatory agencies, research funding organisations, academia, pharmaceutical and medical technology industry, contract research organisations (CROs), small and medium-sized enterprises (SMEs), and startups, to align national and regional policies for speeding up the development, validation, acceptance, and uptake of NAMs.

This action will be supported by four working groups with the themes: (1) development of NAMs and common European infrastructures, (2) validation/qualification, acceptance, and uptake of NAMs, (3) education and training, (4) openness & awareness.

Objective

The action aims to accelerate, through an aligned and coordinated approach across Member States and, where appropriate, Associated Countries, the development, validation/qualification, acceptance, and uptake of new approach methodologies (NAMs) in biomedical research and regulatory testing of medicinal products and medical devices.

Expected outcomes

• NAM development and infrastructure agenda identifying where NAMs are most needed and expected to have the highest short- to medium-term impact (Q4 2027);
• Member States and stakeholders identify actions they could jointly support to develop new NAMs and related infrastructures (Q1 2028);
• NAM acceptance and uptake strategy which identifies criteria for using NAMs (Q3 2027);
• Member States and stakeholders jointly supporting the validation and qualification of a limited set of NAMs designed to be accepted and implemented in regulatory testing of medicinal products and medical devices (Q4 2027-Q3 2028);
• NAM education and training plan (Q1 2027) and joint education and training programmes (Q2 2027- Q2 2028);
• Harmonised NAM openness and awareness programme that improves open access to NAMs protocols and results of animal experiments. The programme will provide guidance for ethical committee members, reviewers, and regulators, based on best practices in participating Member States. It proposes concrete actions to increase the confidence of regulators in NAMs including a better understanding of the potential and limitations of NAMs (Q2 2028).
• At least one major conference to raise awareness of civil society and patients on biomedical research, drug discovery and development process (Q3 2028).