EDCTP Call for Proposals: Strengthening regulatory capacity for supporting conduct of clinical trials
The European & Developing Countries Clinical Trials Partnership (EDCTP) on “Strengthening regulatory capacity for supporting conduct of clinical trials” to support 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:
- Enhanced regulatory capacity to conduct clinical trials in sub-Saharan Africa countries, complementing the work of the African Vaccine Regulatory Forum (AVAREF);
- Increased common regulatory mechanisms across sub-Saharan Africa countries, including better alignment with regional standards and overarching continental mechanisms such as the African Medicines Agency;
- Better equipped health systems to integrate new or improved health technologies;
- Improved efficiency regarding the process of market authorisation of new or improved health technologies;
- Improved efficiency of the National Regulatory Agencies (NRAs) concerning clinical trials oversight;
- Lessons and principles that will help continental or regional Regulatory Agencies in sub-Saharan Africa to better define their function, frameworks and capabilities;
- Stronger African ownership and leadership of clinical research in sub-Saharan Africa countries;
- Better collaboration between NRAs and national and institutional research ethics committees, research integrity offices and data access committees;
- Accelerated maturity towards level 4 of the Regulatory Agencies in sub-Saharan Africa.
Scope:
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.
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.
Read more here.
Proposals deadline August 30, 2022.
