EDCTP Ethics and Regulatory Capacities Programme: Supporting Sub-Saharan African Countries

Deadline: 22 November 2016

The European and Developing Countries Clinical Trials Partnership (EDCTP) is currently inviting applications for its Ethics and Regulatory Capacities Programme with an aim to provide funding to actions that aim to support sub-Saharan African countries to establish and develop robust national medicines regulatory systems and capacities for ethical review of clinical research and use of medicinal products and technologies for use in humans. This scheme targets both National Ethics Committees (NECs) and National Regulatory Authorities (NRAs).

Objectives

• To support NECs’ development of institutional and personnel capacities to enable them to perform their national ethical oversight function over the institutional review boards; efficiently review clinical trial applications; and to provide ethical oversight for clinical trials and health research in general;
• To support NRAs’ development of institutional and personnel capacities to enable improved regulatory pathway activities directly related to clinical trials and registration of new medicinal products. This may also include strengthening pharmacovigilance systems.

Funding Information

• The call budget is 2 million EUR.
• The total requested EDCTP contribution shall not exceed 300,000 EUR.
• EDCTP may fund 100% of eligible project costs.

Eligibility Criteria

• At least one legal entity established in a European Participating State (1) or a sub-Saharan African country (2).
• Applications must include at least one legal entity hosting NECs or NRAs in sub-Saharan African countries (3).
• The requested EDCTP contribution per action shall not exceed €300,000.

How to Apply

• This is a single-stage application procedure.
• Applications must be submitted online via the given website.

Eligible Countries

• European Countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.
• Sub-Saharan African Countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Sudan, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

For more information, please visit EDCTP Ethics and Regulatory Capacities Programme.