Strengthening regulatory capacity for supporting conduct of clinical trials

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:

• 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.

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:

• Desk review and mapping of the clinical research oversight and pharmacovigilance systems across the involved sub-Saharan Africa countries through country questionnaires and (virtual) participatory workshops to identify gaps and needs;
• Develop approaches and provide training to develop personal and institutional capacities on clinical trial oversight and pharmacovigilance of the NRA staff, researchers, clinicians and other healthcare workers, including knowledge exchange through South-South and North-South partnerships;
• NRAs should recruit at least two new staff members to be trained on clinical trials regulatory framework and be integrated, with a well-defined function and objectives, in the participating Agency in a systems approach. The new staff members should stay in the Agency team for at least two years and participate in networking events, such as the Scientific Conference on Medical Products Regulation in Africa;
• Facilitate and promote harmonised regulatory pathways for clinical research and joint assessment of market authorisations in line with regional and national guidelines;
• Define strategies or practices that can inform policy revisions to improve the efficiency of the NRAs, by introducing innovative systems, practices, and/or technologies that improve the quality and timelines of these bodies as regards clinical research oversight and clinical research pharmacovigilance;
• Promote international cooperation in clinical research regulatory activities with regional and international regulatory harmonization bodies by transferring promising and successful innovative systems and/or technologies from other regions outside Africa and within Africa, fostering national and regional collaboration with regional and international regulatory harmonization bodies;
• Strengthen linkages between regulatory functions and clinical trial registries, such as the Pan African Clinical Trials Registry (PACTR: https://pactr.samrc.ac.za/), while enforcing data sharing in compliance with global requirements;
• Support already established training centres to provide both innovative clinical research training and mentorship to NRAs;
• Plans to foster links between NRAs and initiatives reinforcing collaboration between NRAs and National Ethics Committees in sub-Saharan Africa.

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)^[1]. 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^[2], The health systems dimension of the Global Gateway investment package^[3], various Team Europe initiatives such as the Team Europe initiative (TEI) on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+) in Africa^[4].

[1] 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

[2] 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/

[3] Global Gateway investment package https://ec.europa.eu/info/strategy/priorities-2019-2024/stronger-europe-world/global-gateway/eu-africa-global-gateway-investment-package_en

[4] 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).