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 Poli