Support to European Research Area (ERA) action on accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:

• Member States and relevant stakeholders identify priority areas where New Approach Methodologies (NAMs) and infrastructures are most needed and expected to have the highest short- to medium-term impact.
• Member States and other stakeholders jointly support the validation and qualification of a limited set of NAMs that are intended to be accepted and implemented in regulatory testing of medicinal products and medical devices.
• Member States and other stakeholders develop common education and training programmes based on best practices identified in European and non-European countries to better inform researchers and regulators on NAMs and on the application of the 3Rs principles[1].
• Member States and other stakeholders implement a harmonised NAM openness and awareness programme that improves open access to NAMs protocols and results of animal experiments. It also provides guidance to harmonise the awareness of NAMs for ethical committee members, reviewers, and regulators, based on best practices in the participating Member States. The programme should propose concrete actions to increase the confidence of regulators in NAMs including a better understanding of the potential and limitations of NAMs.

Scope

This topic aims to coordinate and develop the new European Research Area (ERA) policy action to accelerate, through an aligned and coordinated approach across Member States and Associated Countries, the development, validation/qualification, acceptance, and uptake of NAMs in biomedical research and regulatory testing of medicinal products and medical devices as part of the ERA Policy Agenda 2025-2027[2].

The ERA action should establish an EU-wide forum that brings together relevant ministries, regulatory agencies, research funding organisations, academia, industry (pharmaceutical and medical technology), Contract Research Organisations (CROs), small and medium-sized enterprises (SMEs)[3], and startups to harmonise policies and strategies for NAMs development and implementation.

The selected proposal should be coordinated by any active participant to the ERA action to ensure consistency with ERA action policy objectives. It should contribute to the implementation of the following themes of the four thematic Working Groups (WGs) of the ERA action:

WG1: Development of NAMs and common European infrastructures. This WG identifies opportunities for the development and integration of NAMs and the establishment of supporting infrastructures. Its focus spans specific disease or biological areas and safety, quality, and efficacy assessment endpoints for medicinal products and medical devices. The WG provides insight and suggests priorities to governments and industry for the further coordinated efforts to leverage promising development of NAMs, taking into consideration the complementarity of scientific strengths, funding priorities and available expertise in the different Member States and regions.

WG2: Validation, acceptance, and uptake of NAMs. The WG defines optimal criteria for NAMs to facilitate their uptake in the contexts of basic and applied biomedical research, and their acceptance for the regulatory assessment and eventual approval of medicinal products and medical devices within defined contexts of use. It proposes priorities for the validation and qualification of NAMs. Member States and pharma/MedTech industry take the decision to jointly support the validation/qualification of certain NAMs that are sufficiently mature for acceptance and uptake in regulatory testing of medicinal products and medical devices.

WG3: Education and training. The WG maps existing education and training programmes on NAMs and the 3Rs principles and assesses their quality and outreach. The WG makes suggestions to Member States based on the best practices identified for the joint development of high-quality education and training modules on NAMs and the application of the 3Rs principles in close partnership with education directors at knowledge institutes.

WG4: Openness and awareness. The WG develops common policies to improve the openness and quality of research, including open access to available protocols on NAMs, and facilitating the publication of results from NAMs and animal experiments, even if these are negative or neutral (or historic, if feasible and appropriate), to avoid unnecessary duplication of animal testing or development of non-valid NAMs. It considers strategies for sharing best practices to make sure that different ethical committees, funding assessment committees, reviewers, and regulators have a similar level of awareness regarding the latest scientific advancements in available NAMs. It proposes actions to enhance the confidence of regulators in validated and qualified NAMs. The WG also identifies opportunities for raising awareness among civil society and patients regarding the biomedical research, drug discovery and development process.

The European Commission's Joint Research Centre (JRC) may contribute to the proposal selected for funding, particularly with activities on innovative in vitro biotechnologies.

[1] Replacement, Reduction, Refinement: https://nc3rs.org.uk/who-we-are/3rs

[2] Proposal for a Council Recommendation on the European Research Area Policy Agenda 2025-2027: https://european-research-area.ec.europa.eu/documents/proposal-council-recommendation-european-research-area-policy-agenda-2025-2027

[3] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361