Paediatric drug formulations for poverty-related diseases 2019
Call budget: € 18 million
Funding level: 100% of eligible costs
Stage 1 Open date: 10 June 2019, Stage 1 Close date: 10 October 2019 Stage 2 Open date: 21 December 2019, Stage 2 Close date: 16 March 2020
Poverty-related diseases (PRDs) remain the leading causes of morbidity and mortality in sub-Saharan Africa, especially during childhood. Despite progress in other age groups, effective treatment and prevention of PRDs in paediatric populations is often lacking and/or lagging. The frequent exclusion of children and adolescents from clinical trials and the paucity of available products that target this group are factors that contribute to this population having one of the lowest health indicators. Additional challenges relate to the limited financial incentives associated with the adaption of off-patent medicines to the specific needs of paediatric populations. Therefore, concerted efforts are needed to increase access to potentially life-saving, cost-effective interventions to prevent and treat PRDs in children and to enhance the use of existing interventions in this population.
Proposals should focus on the adaptation of existing medicinal products (drugs), including off-patent products, to the specific needs of children (0-17 years of age). Proposals may address any of the PRDs within the remit of the EDCTP2 programme. Proposals should include one (or more) clinical trials conducted in sub-Saharan Africa to assess the safety, efficacy and pharmacokinetics of the drug(s), and/or the development of age-appropriate formulations. Projects must assure that the clinical trials are conducted appropriately, in line with guidelines on pharmaceutical development of medicines for paediatric use*, respecting current legislation and considering the ethical aspects and particular needs of the study subjects and their families. Applicants should seek advice on the clinical trial design from the appropriate regulatory agency(ies) before developing the application. The EDCTP Association considers that proposals for actions of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately.
The clinical need for paediatric dosing should be clearly explained in the proposal. The proposal must include full details of the strategy for the clinical paediatric development, including product development milestones and go/no-go criteria for the proposed clinical trial(s) as well as specific plans for the subsequent regulatory approval process, ideally a paediatric investigation plan, which should aim at obtaining a relevant market authorisation such as the Paediatric Use Marketing Authorisation (PUMA) or equivalent.
The actions supported under this call should have the potential to achieve maximum impact in the field and to make a significant contribution to the objectives of the EDCTP2 programme, and in particular:
- contribute towards the development or adaptation of medicinal products for use in children;
- lead to the advancement of new drugs and/or drug combinations, with the aim of registration of new drug(s) and/or drug combinations for treatment and prevention of PRDs in children in sub-Saharan Africa and globally;
- contribute to the reduction of mortality and morbidity in sub-Saharan Africa, particularly in children and thus contribute to achieving SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages’.
A 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 for participation set out below, depending on the type of action:
- At least three legal entities. Two of the legal entities shall be established in two different Participating States (European Partner States)** and one of the legal entities must be established in a sub-Saharan African*** country. All three legal entities must be independent of each other;
- ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.
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*Guideline on pharmaceutical development of medicines for paediatric use EMA, 1 August 2013
**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.