The REFINE Project White Paper Anticipation of Regulatory needs for nanotechnology-enabled health products

The REFINE White Paper summarises the regulatory challenges for nanotechnology-enabled health products inviting stakeholders from different communities for a wider debate.

Nanotechnology can significantly improve properties of medical products and devices providing innovative solutions in the area of therapy, diagnosis and prevention of diseases. Nanotechnology-enabled health products follow current regulatory frameworks for medicinal products or medical devices. However, their specific properties and complexity may require additional regulatory guidance and more sophisticated methods to assess their quality and safety profile.

The European project REFINE  has taken up the challenge to address regulatory questions and develops currently a portfolio of methods filling existing methodological gaps which are needed in preclinical assessments of nanomedicines. As a major deliverable of the project, the REFINE’s white paper provides an overview on the identified challenges in the field and delivers a summary on relevant legislative/regulatory frameworks and involved organisations. More efforts are needed to take up translational and regulatory science into academic research and educational programmes in order to support the development of regulatory structures that can be adaptive to increasingly complex innovative health products such as nanomedicines. December 2019