Wednesday, 23 July 2025 14:06

Council of the European Union recommends accelerating the expansion of NAM for research and testing Featured

On June 24, a European Council Recommendation on a policy agenda for the European Research Area 2025-2027 was published.


At the proposal of the European Commission, the European Council recommends that, due to multiple and unprecedented challenges, the EU should focus more decisively on research and innovation in Europe in order to reduce Europe's weaknesses and realize its full potential across the whole European Research Area (ERA).

Although significant progress has been made since 2022 under the first policy agenda, more must be done to develop a fully operational ERA. The second ERA policy agenda 2025-2027, which has now been published, is designed to strengthen national research and innovation systems and address the complex global challenges facing Europe.

For example, under priority area no. 2, in addition to an increase in investment in research and innovation, an acceleration of new approach methodologies (NAMs) is explicitly recommended.

The aim of the measure is to drive forward the development, validation/qualification, acceptance and introduction of methods based on new approach methodologies (NAMs) in biomedical research and in regulatory testing of pharmaceuticals and medical devices through a concerted and coordinated approach in the Member States and, where appropriate, associated countries.

Although the Member States are bound by Directive 2010/63/EU, which calls for the avoidance of animal testing in research, education and regulatory testing as soon as validated alternative approaches are available. However, there is currently no coordination mechanism to ensure the development and validation of NAMs.

All stakeholders will be actively involved in the ERA action by establishing an EU-wide coordination involving relevant ministries, regulatory bodies, research funding organizations, universities, the pharmaceutical and medical industry, contract research organizations (CROs), small and medium-sized enterprises (SMEs) and start-ups.

Source and further information:
Council Recommendation of 24 June 2025 on the European Research Area Policy Agenda 2025-2027 (Text with EEA relevance), ST/9236/2025/INIT.
https://eur-lex.europa.eu/eli/C/2025/3593/oj
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Choose Europe for life sciences - A strategy to position the EU as the world’s most attractive place for life sciences by 2030. COM/2025/525 final
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025DC0525