Strengthening regulatory capacity for supporting conduct of clinical trials
This program, part of the Global Health EDCTP3 Joint Undertaking, aims to significantly enhance regulatory capacity and technical expertise for clinical trials in sub-Saharan African countries. It addresses crucial gaps in health systems, promotes harmonized regulatory pathways, and supports the efficient market authorization of new health technologies, thereby strengthening African leadership in clinical research.
Who is Funded
This section details the eligibility criteria for applicants, the geographical scope of the program, and its overarching objectives. Funding is directed towards legal entities established in EU Member States, associated countries, or specific EDCTP Association member countries, aiming to enhance regulatory capacity for clinical trials across sub-Saharan Africa. The primary goal is to improve health systems and accelerate market authorization processes for new health technologies.
What is Funded
This section outlines the types of projects and activities eligible for funding, focusing on strengthening regulatory systems and technical expertise for clinical trials in sub-Saharan Africa. The program supports activities designed to improve clinical trial oversight, pharmacovigilance, and the market authorization process for health technologies.
Type and Scope of Funding
This section describes the financial instrument used for this program and the typical funding amounts allocated per project. The funding is provided as grants, supporting Coordination and Support Actions designed to build regulatory capacity.
Conditions and Requirements
This section details the essential conditions and requirements for applicants and beneficiaries, covering general admissibility, financial and operational capacities, and specific aspects related to consortium composition and legal frameworks. Proposals are evaluated based on excellence, impact, and implementation quality.
Application Procedure
This section outlines the process for submitting applications and how projects are evaluated and selected. The submission and evaluation procedures follow the guidelines set out in the Horizon Europe framework, with a single-stage submission and specific scoring thresholds for evaluation criteria.
Legal Basis
This section provides the foundational legal and official documents that govern the "Strengthening regulatory capacity for supporting conduct of clinical trials" funding program, rooted in the broader Horizon Europe framework.
Similar Programs
Funding Overview
Funding Status:
Closed
Maximum Amount:
600,000 €
Allocated Budget:
5,000,000 €
Award Channel:
Framework Programme Call
Region:
European Union (Member States, OCTs), Horizon Europe Associated Countries, Burkina Faso, Cameroon, Congo, Côte d’Ivoire, Ethiopia, Gabon, The Gambia, Ghana, Kenya, Mali, Mozambique, Niger, Nigeria, Senegal, South Africa, Tanzania, Uganda, United Kingdom, Zambia
Sectors:
Healthcare, Research and Development, Other
Beneficiaries:
Regulatory Agencies, Researchers, Clinicians, Healthcare Workers
Application Type:
Consortium Required
Funding Stages:
Capacity Building, Implementation, Policy Development
Funding Provider
Program Level:
European Union
Funding Body:
Global Health EDCTP3 Joint Undertaking (GH EDCTP3 JU)
Additional Partners:
African Vaccine Regulatory Forum (AVAREF), Pan-African Clinical Trials Registry (PACTR), African Medicines Regulatory Harmonisation (AMRH), African Medicines Agency (AMA), Regional Centres of Regulatory Excellence in Africa (RCOREs), African Medicines Quality Forum (AMQF), Africa Centre for Disease Control and Prevention (Africa CDC), Regional Economic Communities, European Medicines Agency (EMA), AUDA-NEPAD (AMA), World Health Organisation (WHO), EDCTP Regional Networks of Excellence, Global Gateway investment package, Team Europe Initiative (TEI) on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+)
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