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Regulatory Science Framework for assessment of risk benefit ratio of Nanomedicines and Biomaterials


Proposals should advance the field of medical regulatory science and practice through the development and validation of science based regulatory knowledge and standardisation of innovative technical tools and methods. The intention is to lead to a new and better methodology for pre-clinical and clinical evaluation and help to take appropriate stock of and to apply innovative scientific advances as and when they occur. As relevant, the proposed activities should address sex and gender specific aspects [See definition of the 'gender dimension approach' in the introduction of this Work Programme part.].

Proposals should focus on the development of new regulatory standards and tools that are based on scientific principles that already have a Proof-of-Concept at the laboratory scale.

Where appropriate, proposals should make use of the opportunities for obtaining scientific advice from medical regulatory bodies to support the qualification of innovative development methods.

International cooperation and participation of Member States funding programmes with complementary funding is encouraged to facilitate development of new regulatory science on the global scale.

Established methods, including related equipment, should be brought to Technology Readiness Level 6 and beyond, whereas those based on new concepts are expected to reach TRL 5.

This topic is suitable for international cooperation.

The Commission considers that proposals requesting a contribution from the EU between EUR 5 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

No more than one action will be funded.

The application of nanotechnology and nanobiomaterials has great potential to advance medicine for the benefit of citizens. However, the use of these new technologies poses considerable challenges for assessing the quality, safety and efficacy of the novel nanomedicines and medical devices.

  • To reduce the cost of pre-clinical and clinical development for new medical products and therapies, that are based on the application of nanotechnology and nanobiomaterials;
  • To reduce the time for innovations to reach the patients;
  • To provide a set of tools for more informed risk assessment and decision making;
  • To improve standardisation of regulatory practice at the European and international level;
  • To establish a close collaboration among regulators, industry, science and patients with regard to the knowledge required for appropriate risk management, and create the basis for common approaches, mutually acceptable datasets and risk management practices;
  • To establish a European Consortium for the Advancement of Regulatory Science in Biomaterials and Nanomedicines, involving industrial, medical, academic, regulatory and patient representative stakeholders;
  • To identify within the consortium critical issues for innovative products and establishment of an action plan for further studies;
  • To establish links with existing European Infrastructures active in the field, along with relevant European Research Networks;
  • To elaborate an action plan for a better integration of the European Union with other regions of the world.