Programme Category
Programme Name
Programme Description
The Global Health EDCTP3 Joint Undertaking (GH EDCTP3) builds on the first and second European and Developing Countries Clinical Trials Partnership programmes. This new joint undertaking (JU) is a partnership between the EU and the EDCTP Association, whose members are several European and African countries. The partnership will deliver new solutions for reducing the burden of infectious diseases in SSA and strengthen research capacities to prepare and respond to re-emerging infectious diseases in this region and across the world.
Identifier Code
Call
Summary
Proposal under this topic should aim to deliver results that are directed towards, and contributing to all of the following expected outcomes:
- Health care providers and professionals have access to novel or improved point-of-care diagnostic (POC) devices that are suited to rapidly detect infectious diseases of relevance in sub-Saharan Africa (SSA) and within the scope of the Global Health EDCTP3 Scientific Research and Innovation Agenda.
- A diverse and robust pipeline of in vitro diagnostics is available, increasing options for clinical deployment, also in case of an infectious diseases outbreak with epidemic or pandemic potential, that can reach the most vulnerable populations.
- Health authorities and health care systems have access to health data and evidence to better develop and implement informed health policies and improved clinical surveillance of infectious diseases in SSA.
Detailed Call Description
Proposals should address all of the following areas:
- Clinical performance studies in several sites across SSA of POC diagnostics that are of high technology readiness level to achieve regulatory approval and market launch (i.e., CE mark); postmarket surveillance studies are excluded from this call and are covered by other initiatives such as the African Health Diagnostics Platform;
- Studies need to provide evidence-based practice for the POC diagnostic test especially in terms of the ability to decide on treatment options after diagnosis and improving disease outcome;
- the possibility of the POC diagnostic to be deployed in the field, its usability by primary care and community health care workers in resource-limited patient communities should be especially considered;
- Inclusion of a clear regulatory path to market to ensure future compliance with the legal requirements; early engagement with regulatory authorities is expected;
- Product development plans for translation from prototype to industrial design, to implementation and sustainability of the innovation should be provided, also including a plan for the process of “sample to result to the use of result & treatment option” and how to report data & results (e.g., via mobile health/portable technology);
- Where available and relevant, World Health Organization target product profiles for diagnostics need to be addressed;
- Involvement of industry, notably of small and medium-sized enterprises (SMEs), especially African SMEs, is expected.
Proposals submitted under this topic should implement clinical studies that lead to market authorisation of the relevant POC diagnostic test. The POC diagnostic test device should be aimed at detection of diseases that currently lack POC diagnosis tests or where POC diagnostics are inadequate.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
EU Contribution per project: € 5 000 000
Thematic Categories
- Health
- Research, Technological Development and Innovation
- Small-Medium Enterprises and Competitiveness
Eligibility for Participation
- Central Government
- Large Enterprises
- NGOs
- Non Profit Organisations
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- Small and Medium Enterprises (SMEs)
- State-owned Enterprises
Eligibility For Participation Notes
Participants will be subject to additional exploitation obligations shown in page 31-32 of the Annex 1 of the Global Health EDCTP3 Work Programme 2023: call topics.
Involvement of African SMEs is highly encouraged to contribute to developing the African industry and access to health products.
Call Opening Date
Call Closing Date
EU Contact Point
EDCTP – Europe Office
Postal and visiting address
Anna van Saksenlaan 51
2593 HW The Hague, The Netherlands
Telephone: +31 70 344 0880
EDCTP – Africa Office
Postal address
P.O. Box 19070, Tygerberg 7505
Cape Town, South Africa
Visiting address
Francie van Zijl Drive,
Parowvallei 7505
Cape Town, South Africa
Telephone: +27 21 938 0690
Fax: +27 21 938 0569
Contact Form in the website