This topic aims at supporting activities that are contributing to one or several of the expected impacts for this call. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to the following expected outcomes:
The purpose of this call for proposals is to fund projects designed to support regulatory capacity and develop technical expertise reinforcing regulatory systems in sub-Saharan Africa countries for supporting the conduct of clinical trials.
These objectives should contribute to strengthening frameworks and capabilities, including issuance of relevant permits, clinical trials oversight and clinical research pharmacovigilance and post-trial market authorisation by NRAs. The funded projects should train researchers, clinicians and Regulatory Agency authorities' personnel for an efficient and robust regulatory control system for approving the conduct of clinical trials and for a responsive clinical trials pharmacovigilance.
The proposals should address several of the following activities:
Proposals should clearly describe the national mismatch between disease burden, research activity and level of regulation that justify the need for support. Proposals should explain the links of the proposed activities to existing regulatory initiatives, such as the Africa Vaccines Regulators Forum (AVAREF), the Pan-African Clinical Trials Registry (PACTR), the African Medicines Regulatory Harmonisation (AMRH), the African Medicines Agency (AMA) and the Regional Centres of Regulatory Excellence in Africa (RCOREs). Other regional bodies to be taken into account where appropriate are the African Medicines Quality Forum (AMQF), Africa Centre for Disease Control and Prevention (Africa CDC) and Regional Economic Communities.
Particular attention should also be paid to ensuring complementarity and coherence with other activities supported by the European Union and EU Member States in the countries involved in the proposal; for example: EDCTP Regional Networks of Excellence, The health systems dimension of the Global Gateway investment package, various Team Europe initiatives such as the Team Europe initiative (TEI) on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+) in Africa.Cross-cutting Priorities:
African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative. There are currently 11 RCOREs throughout Africa: https://www.nepad.org/publication/regional-centres-regulatory-excellence-rcores
EDCTP regional networks of excellence strengthen regional networking and provide platforms for research training and multicentre studies http://www.edctp.org/our-work/edctp-regional-networks-of-excellence/
Team Europe Initiative on Manufacturing and access to vaccines, medicines and medical technologies (MAV+) will directly fund, starting in 2022/2023, the European Medicines Agency (EMA), African Medicine Agency AUDA-NEPAD (AMA) and the World Health Organisation (WHO).