Horizon Europe 'Health' - New Approach Methodologies (NAM) for regulatory safety and efficacy testing

HORIZON-HLTH-2024-IND-06-09: Gaining experience and confidence in New Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and experience exchange for regulators

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:

• European regulators gain state-of-the-art knowledge on different NAMs that are being proposed for the assessment of the safety and efficacy of chemicals and pharmaceuticals;
• European regulators understand better the shortcomings of the current tools based on animal procedures for the assessment of chemicals and pharmaceuticals;
• European regulators collaborate on a framework on how to assess the safety of chemicals based on NAM-data and how to classify the hazardous properties based on such data;
• European regulators collaborate on a similar framework for assessment of safety and efficacy of pharmaceuticals based on NAM-data;
• Citizens benefit from the supply and use of chemicals and pharmaceuticals that have been assessed through NAMs that are better predicting potential effects in humans than the current assessment methods;
• Industry has an improved competitive position with the availability of harmonised and standardised NAM-based assessment tools that are faster and more flexible;
• European Commission and Member States regulators are responding to the societal demand to move away from animal testing.

Deadline: 11 April 2024, 17:00 CEST