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
The aim of this call is to improve the functionality, recognition and performance of NECs and NRAs for carrying out clinical trials in SSA countries.
The projects funded under this call will support the SSA countries to establish and/or develop own robust capacities for ethics review and national medicines regulatory systems. This also includes support towards national and international collaboration in compliance with established international standards. This scheme targets proposals with active involvement of NECs and/or NRAs from SSA countries, and in particular with those countries with the highest infectious disease burden.
Detailed Call Description
Proposals should address several of the following activities:
- Improvement of the efficiency of the functioning of NECs and NRAs through the introduction of innovative systems, reliance practices and/or technologies that would facilitate the various functions of these bodies with better quality outputs and improved timelines;
- Development of national health research legislation;
- Promotion of quality control systems and processes for NECs and NRAs, as well as certification and accreditation of the various bodies, as well as adherence to international standards;
- Promotion of international cooperation in ethics and regulatory activities through transfer of promising and successful innovative systems and/or technologies from other regions in Africa or other continents, fostering national and regional collaboration among these bodies;
- Creation of linkages between ethics and regulatory functions with other important structures, such as clinical trial registries, whilst simultaneously enforcing the sharing of data in compliance with global requirements;
- Promotion of the adoption and update of AVAREF, WHO and other international standards and best practices, by countries, groups of countries, or regional harmonisation initiatives;
- Support already established training centres to provide both innovative training, and mentorship to NECs and NRAs.
- Development or scale-up of innovative systems and technologies that support ethics and regulatory functions, training, networking and promotion of good practices and evidence-based adoption of accreditation models from relevant internationally endorsed/peer-reviewed documented sources.
Proposals should clearly indicate the mismatch between the country disease burden, research activity and level of ethical review and regulatory oversight that justify the need for support in these areas.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
Expected EU contribution per project: €1 000 000
Thematic Categories
- Health
- Research, Technological Development and Innovation
Eligibility for Participation
- Researchers/Research Centers/Institutions
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