Deadline: 22 November 2018
The European and Developing Countries Clinical Trials Partnership (EDCTP) is currently seeking proposalsfor its Ethics and Regulatory Capacities Programme 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, as well as national and international collaboration. This scheme targets both NECs and NRAs.
ObjectivesThe objectives of this call are:
- 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.
- The call budget is €4.5 million.
- The requested EDCTP contribution per project should not exceed 300,000 EUR. The funding level is 100% of eligible costs.
Eligibility CriteriaA proposal/application will only be considered eligible if:
- its content corresponds, wholly or in part, to the topic/contest description for which it is submitted.
- it complies with the eligibility conditions set out below, depending on the type of action:
- At least one legal entity established in a European Participating State or a sub-Saharan African country (mentioned below).
- In addition, applications must include at least one legal entity hosting NECs or NRAs in sub-Saharan African countries.
- The requested EDCTP contribution per action shall not exceed 300,000 EUR.
How to Apply
- This is a single-stage application procedure.
- Proposals must be submitted online via the given website.
- 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, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.
- For more information, please visit Ethics and Regulatory Capacities.