TOPIC : Regulatory Science Framework for assessment of risk benefit ratio of Nanomedicines and Biomaterials
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Opening date:||two-stage 11 May 2016||Deadline: 2nd stage Deadline:||
27 October 2016 17:00:00
04 May 2017 17:00:00
|Time Zone : (Brussels time)|
11 January 2017 10:28
Switzerland as associated country
From 1 January 2017 Switzerland is associated to the whole Horizon 2020 programme instead of the previous partial association.
This applies to all the grant agreements signed on 1 January 2017 and afterwards.
For more information please see the relevant Note on the Participant Portal.
Topic DescriptionSpecific Challenge:
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.Scope:
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.
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.Expected Impact:
- 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.
See definition of the 'gender dimension approach' in the introduction of this Work Programme part.
Topic conditions and documents
Please read carefully all provisions below before the preparation of your application.
- LIST OF COUNTRIES and APPLICABLE RULES FOR FUNDING
described in part A of the General Annexes of the General Work Programme.
Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects (follow the links to Australia, Brazil, Canada, China, Hong Kong &Macau, India, Japan, Republic of Korea, Mexico, Russia, Taiwan).
- ELIGIBILITY and ADMISSIBILITY CONDITIONS
described in part B and C of the General Annexes of the General Work Programme.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
3.1 Evaluation criteria and procedure, scoring and threshold:
The criteria, scoring and threshold are described in General Annex H of the work programme.
The following exceptions apply:
For single-stage and second-stage evaluations, the threshold for the criteria Excellence and Impact will be 4. The overall threshold, applying to the sum of the three individual scores, will be 12.
The procedure for setting a priority order for proposals with the same score is given in General Annex H of the work programme. The following exceptions apply:
Under 3 (a)
Proposals are first ranked in separate lists according to the topics against which they were submitted (‘topic ranked lists’). When comparing ex aequo proposals from different topics, proposals having a higher position in their respective 'topic ranked list' will be considered to have a higher priority in the overall ranked list.
Under 3 (b)
For all topics and types of action, the prioritisation will be done first on the basis of the score for Impact, and then on that for Excellence.
3.2 Submission and evaluation process: Guide to the submission and evaluation process
- INDICATIVE TIMETABLE for EVALUATION and GRANT AGREEMENT
Information on the outcome of two-stage evaluation:
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
- PROVISIONS, PROPOSAL TEMPLATES and EVALUATION FORMS
for the type of action under this topic
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
- ADDITIONAL PROVISIONS
Horizon 2020 budget flexibility
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Financial support to Third Parties – where a topic description foresees financial support to Third Parties, these provisions apply.
- OPEN ACCESS
Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
- Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs.
- Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
- ADDITIONAL DOCUMENTS
Legal basis: Horizon 2020 - Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
H2020 Work Programme 2016-17: Introduction
H2020 Work Programme 2016-17: Introduction to Leadership in enabling and industrial technologies (LEITs)
H2020 Work Programme 2016-17: Nanotechnologies, advanced materials, advanced manufacturing and processing, biotechnology
H2020 Work Programme 2016-17: Cross-cutting activities (Focus Areas)
H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
H2020 Work Programme 2016-17: General Annexes
No submission system is open for this topic.
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