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

February 2020

REFINE PROJECT follows the latest EC published Report on the definition of nanomaterials.

The European Commission has recently published in the JRC Science for Policy Report journal, An overview of concepts and terms used in the European Commission’s definition of nanomaterial.

The report addresses its key concepts and terms and discusses them in a regulatory context. Corresponding to the broad scope of the definition the considerations in this report can be applied across all relevant legislative areas; they are not specific to any particular piece of legislation. The report provides recommendations for a harmonised and coherent implementation of the nanomaterial definition in any specific regulatory context at European Union and national level.

More information and report download available at:

October 2019


REFINEs New Coordinator

REFINE consortium welcomes the newly elected project coordinator Kathleen Spring from Gesellschaft für Bioanalytik Münster e.V., Germany, she succeeds Patrick Boisseau. She holds a PhD in Molecular Biology from the University of Montreal, Canada and was trained afterwards as a Postdoc at Max Planck Institute for Molecular Biomedicine in Münster. She now works at Gesellschaft für Bioanalytik Münster e.V. and joined recently the ETP Nanomedicine Executive Board board as secretary.
September 2019

December 4th REFINE & GOV4NANO Coordination Meeting Utrecht, The Netherlands

Meeting date: 4th December 2019 venue: Utrecht

The coordinators and community bridging partners of the two HORIZON 2020 projects REFINE and GOV4NANO met during the projects’ General Assembly and Regulatory Risk Analysis Summit in Utrecht to discuss common ground and connection points for a future collaboration. As both projects aim to develop a framework either for Regulatory Science for nanobiomaterials (REFINE) or for Nano Risk Governance (GOV4NANO), we identified many complementary topics. The projects can fertilise each other since both aim to identify regulatory (REFINE) or transdisciplinary knowledge gaps (Gov4Nano) in the field of nanotechnology and want to build a cross-community network. We are looking forward to further collaboration.

December 3rd-4th 2019 REFINE Consortium General Assembly Meeting Utrecht, The Netherlands

Meeting date: 3rd-4th December 2019 venue: Utrecht

The REFINE General Assembly was characterised by lively and productive discussions which provided valuable inputs and actions to implement during the second part of the project. Prior to the G.A., a very effective Decision Support System Stakeholder Interaction Workshop (the day before) provided grounds for the attendees including the advisors to appreciate the level of work and commitment of the project in the first 24 months.

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

December 2nd 2019 REFINE Decision Support System Stakeholder Interaction Workshop, Utrecht The Netherlands

Meeting Date: 2nd December 2019 Venue: Utrecht

September 18th 2019 Report Review Meeting, Brussels Belgium

Meeting Date: 18th September 2019. Venue Brussels

REFINE consortium met for the 18th month Report Review Meeting at EU Commission in Brussels, to discuss the work of the REFINE partners across the different packages

September 11th-13th IPTC 2019 International Particle Toxicology Conference, Salzburg Austria

Meeting dates: 11th – 13th September 2019. Venue: Salzburg

July 21st-24th 2019 Controlled Release Society Annual Meeting & Exposition, Valencia Spain

Meeting dates: 21st – 24th July 2019. Venue: Valencia

June 25th-26th 2019 MedFit, Lille France

Meeting dates:25th-26th June 2019 Venue: Lille

June 17th-19th 2019 NanoMedicine Europe, Braga Portugal

Meeting dates: 17th-19th June 2019 Venue:Braga

June 12th-14th 2019 EuroNanoForum, Bucharest Romania

Meeting dates: 12th-14th June 2019 Venue: Bucharest

May 9th 2019 REFINE Project Meeting, Trondheim Norway

Meeting date: 9th May 2019 venue: Trondheim

April 3rd 2019 REFINE First Knowledge Exchange Conference, Amsterdam The Netherlands

Meeting date:3rd April 2019 venue: Amsterdam. 

December 12th-13th 2018 REFINE General Assembly Meeting, Dübendorf Switzerland

Meeting date:12th-13th December 2018 venue: Dübendorf.  

REFINE consortium met for the first year General Assembly at EMPA in Dübendorf, where to discuss extensively on regulatory science for nanomedicine and nanobiomaterials. 

External Advisory Board member supported the discussion.

November 14th 2018 REFINE WP4 Meeting, Düsseldorf Germany. Consortium meeting on starter assays development

WP4 aims to develop a starter set of assays addressing different preclinical safety issues of nanobiomaterials requested by regulatory agencies. For this purpose assays which were previously developed in the partner laboratories are performed and compared to each other to identify the optimal assay sets.

Representatives from each member of WP4 met in Düsseldorf airport for a one-day-meeting to discuss the current development of the starter assay set for nanobiomaterials. Current assay results were presented and discussed between the members with regards to applicability, reproducibility and performance. The members agreed on next steps to proceed and will develop SOPs for the starter set assays which will be checked for quality assurance under guidance of WP5 afterwards.

September 25th-27th 2018 Summer School ADRITELF, Como Italy

Meeting date:25th-27th September 2018 venue: Como.

Dr Adriele Prina-Mello, Trinity College Dublin, presented case studies focused on translational requirements where the knowledge of the regulatory is very much needed.

September 2018 11th-14th NanoInnovation Conference and exhibition, Rome Italy


Meeting date:11th-14th September 2018 venue: Rome.

Dr Adriele Prina-Mello, Trinity College Dublin, presented on “Next generation Nanomedicine development”. This presentation set the discussion with the nanomedicine stakeholders over the critical aspects for nanomedicine translation.

June 11th 2018 Consortium Meeting, Venice Italy

Meeting date: June 11th 2018 venue: Venice.

REFINE consortium met for the second time since the beginning of the project where to discuss progress and alignment with other H2020 projects and stakeholders initiatives

May 24th 2018 Jornada sobre Nanotoxicidad, Barcelona Spain

Meeting date:may 24th 2018 venue: Barcelona.

Dr Eusebio Gainza, Biopraxis Research, presentet on “Development of a regulatory scientific framework for nanomedicines in Europe”.

Today is REFINE H2020 EC project Kick off meeting.

Next 4 years to develop Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices

#nanomedicine          #biomaterials           #medicaldevices            #horizon2020              #TCD

4th Dececmber 2017