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Gaining experience and confidence in New Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and experience exchange for regulators

General & Misc
Project Size:

Opening Date: 26 October 2023 Deadline Date: 11 April 2024, 17:00 Brussels time

Expected Outcome: This call aims to enhance the capabilities of European regulators in adopting New Approach Methodologies (NAMs) for safety and efficacy assessment of chemicals and pharmaceuticals by achieving the following:

· European regulators acquire advanced knowledge on various NAMs.

· Improved understanding of current tools' limitations based on animal procedures.

· Collaboration on frameworks for chemical safety assessment and classification of hazardous properties using NAM data.

· Collaboration on frameworks for pharmaceutical safety and efficacy assessment using NAM data.

· Citizens benefit from safer and more effectively assessed chemicals and pharmaceuticals through NAMs.

· Industry benefits from harmonized and standardized NAM-based assessment tools, offering faster and more flexible evaluations.

· Response to societal demand for reducing animal testing in regulatory assessments.


Tackling diseases and reducing disease burden:

Unlocking the full potential of new tools, technologies and digital solutions for a healthy society:

Maintaining an innovative, sustainable and globally competitive health industry:

Scope: Addressing the limitations of animal testing and societal demand for alternative methodologies, this call focuses on enhancing the use of NAMs in regulatory safety and efficacy testing of chemicals and pharmaceuticals. Proposals should bridge the gap between NAM developers, users, and European regulators, facilitating the integration of NAMs into legal frameworks and decision-making processes.

Key Activities: Proposals should:

· Develop technical and regulatory readiness criteria for NAMs.

· Support technology transfer to bring NAMs to market.

· Standardize NAMs through international organizations such as OECD, CEN, ISO, ICH, VICH.

· Provide technical training for Contract Research Organizations (CROs) using NAMs for regulatory purposes.

· Promote dialogue among companies, regulatory bodies (e.g., ECHA, EMA, EFSA), and Member States authorities on integrating and interpreting NAM data.

· Identify and propose changes to EU legislation to overcome obstacles and facilitate NAM use.

Collaboration: Encourages collaboration with existing initiatives like the Partnership for the Assessment of Risks from Chemicals (PARC) and the ASPIS cluster. Proposals should consider involving the JRC to leverage its expertise in facilitating the regulatory application of NAMs.

Aim: This funding opportunity seeks to modernize regulatory testing frameworks, moving towards a more ethical, efficient, and human-relevant approach. It aims to establish a solid foundation for the widespread acceptance and use of NAMs, ultimately benefiting public health, the environment, and animal welfare.

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