Background
Many partners contribute towards the establishment and capacity strengthening of ethical review frameworks and medicines regulatory bodies, as well as mapping, coordination, and where appropriate, practical harmonisation of their processes in sub-Saharan Africa. Ensuring sustainable development, country ownership and collaboration among external partners are some of the key elements required to support ethics and regulatory functions in sub-Saharan Africa.
The EDCTP Association has dedicated its efforts to ensure that all sub-Saharan African countries hosting clinical trials have functional and effective ethics and regulatory review structures at institutional, national and regional levels. The current strategy promotes fortification and collaboration of national ethics committees (NECs) and National Regulatory Authorities (NRAs) to allow for long-term development plans building towards strong regional collaboration and harmonisation goals.
Despite ongoing efforts by different partners and agencies, ethics and regulatory oversight in sub-Saharan African countries require targeted attention to address the following gaps:
Scope
The purpose of this call for proposals is to fund projects that are designed to support sub-Saharan African countries to establish and/or develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies in humans, as well as national and international collaboration in compliance with established, internationally acceptable good practices. This scheme targets projects with the active involvement of NECs and/or NRAs from countries with both weak and strong ethics and regulatory capacities in sub-Saharan Africa.
The objectives of this call are to:
This call will support proposed actions that address one or preferably more of the objectives outlined above. Proposals should include support for 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.
Sub-Saharan African countries fit within three categories:
Proposals should clearly indicate the category(ies) of countries involved and how the proposed project will address the objectives of the call in the selected countries.
Each project should have at least two new staff members added to the team and trained in the new functions proposed in the actions.
Linkage of the project to other on-going initiatives, such as the Regional Centres of Regulatory Excellence in Africa*, WHO-TDR-SIDCER (Strategic Initiative for Developing Capacity in Ethical Review), Africa Vaccines Regulators Forum (AVAREF), Pan African Clinical Trials Registry (PACTR); African Medicines Regulatory Harmonisation (AMRH) and regional bodies, such as Africa Centre for Disease Control and Prevention (CDC), and WHO-AFRO is encouraged and should be demonstrated in the application. Plans to foster bi-lateral links between the European Medicines Agency (EMA) and the national regulatory authorities in sub-Saharan Africa are also encouraged.
The EDCTP Association considers that proposals for actions of between 24- and 36-months duration would allow these specific challenges to be addressed appropriately. Nonetheless, this does not preclude submissions and selection of proposals for actions of a different duration.
Expected impact
Projects funded under this call for proposals should:
Eligibility
A proposal/application will only be considered eligible if:
Notes
*African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative. There are currently 10 RCOREs throughout Africa.
**For an up-to-date list of the sub-Saharan African countries that have already been funded under the EDCTP2 Ethics & regulatory capacities call, please see the EDCTP website.
***The Participating States (European Partner States) are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.
****The following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Equatorial Guinea, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.
*****This additional condition for participation according to the Rules for Participation (RfP) Art. 9.5 is required due to the objective of this Coordination & Support Action. It aims to establish and develop robust national medicines regulatory systems and capacities for ethical review of clinical research on and use of medical interventions in humans. It is in line with the activities called for by the EU legislator (EDCTP2 Basic Act, Annex II, objective 1c) and contributes to the specific objectives of the EDCTP2 programme which calls, e.g., for cooperation with sub-Saharan Africa on building their capacity for conducting clinical trials in compliance with fundamental ethical principles, relevant legislation and international standards (EDCTP2 Basic Act, Annex I, Objective 2b).
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