Strengthening ethics and regulatory capacity

The aim of this call is to improve the functionality, recognition and performance of NECs and NRAs for carrying out clinical trials in SSA countries.

Despite ongoing efforts by different partners and agencies, ethics, and regulatory oversight in SSA countries requires prioritisation and ownership by these countries to ensure sustained strengthening with a long-term perspective. There is a need to better understand the challenges that these countries are facing. They include the varied levels of clinical trial activity, with no health research legislation in some of them; as well as the need of better quality control, certification and accreditation of ethics and regulatory bodies, adherence to common international standards and open data access. Coherent linkages between ethics and regulatory functions are needed, as well as linkages with clinical trial registration and more systematic research reviews. Furthermore, better systems and technologies, including more external expertise and digitalisation for processing research application review and handling of documentation and data, are required.

Several initiatives have already established capacity development tools and structures that add value to the capacity development efforts of ethics and regulatory agencies in SSA^[1] and should be taken into consideration.

The projects funded under this call will support the SSA countries to establish and/or develop own robust capacities for ethics review and national medicines regulatory systems. This also includes support towards national and international collaboration in compliance with established international standards. This scheme targets proposals with active involvement of NECs and/or NRAs from SSA countries, and in particular with those countries with the highest infectious disease burden.

Proposals should address several of the following activities:

• Improvement of the efficiency of the functioning of NECs and NRAs through the introduction of innovative systems, reliance practices and/or technologies that would facilitate the various functions of these bodies with better quality outputs and improved timelines;
• Development of national health research legislation;
• Promotion of quality control systems and processes for NECs and NRAs, as well as certification and accreditation of the various bodies, as well as adherence to international standards;
• Promotion of international cooperation in ethics and regulatory activities through transfer of promising and successful innovative systems and/or technologies from other regions in Africa or other continents, fostering national and regional collaboration among these bodies;
• Creation of linkages between ethics and regulatory functions with other important structures, such as clinical trial registries, whilst simultaneously enforcing the sharing of data in compliance with global requirements;
• Promotion of the adoption and update of AVAREF, WHO and other international standards and best practices, by countries, groups of countries, or regional harmonisation initiatives;
• Support already established training centres to provide both innovative training, and mentorship to NECs and NRAs.
• Development or scale-up of innovative systems and technologies that support ethics and regulatory functions, training, networking and promotion of good practices and evidence-based adoption of accreditation models from relevant internationally endorsed/peer-reviewed documented sources.

Proposals should clearly indicate the mismatch between the country disease burden, research activity and level of ethical review and regulatory oversight that justify the need for support in these areas.

Linkages of the proposal to relevant on-going initiatives and regional bodies is encouraged and should be demonstrated.^[2] Plans to foster bi-lateral links between the European Medicines Agency (EMA) and the national ethics and regulatory authorities in the SSA countries of the participants are encouraged.

Each proposal should have at least two new technical staff members recruited to the NEC/NRA team to be trained and integrated in the new functions proposed in the action. The new staff members should have a well-defined function and objectives in the participating NEC and NRA with a systems approach. The new staff members should stay in the team for at least two years and participate in relevant networking and international events.

Particular attention should also be paid in the proposal for ensuring complementarity and coherence with other activities supported by the European Union and EU Member States in the countries involved. This concerns for example the EDCTP Regional Networks of Excellence^[3] and the Team Europe initiative on Manufacturing and Access to Vaccines, Medicines, and Health Technologies (MAV+) in Africa^[4] or other health Team Europe initiatives^[5] of the Global Gateway investment package.

To strengthen the clinical research capacity in the SSA regions with the highest disease burden, the quality of the transfer of knowledge should be taken particularly into account when evaluating the criterion ‘impact’.

Proposals should provide details on the steps to be taken to ensure gender balance and contribute to have representation from French speaking and Portuguese speaking SSA countries in the project team.

^[1]WHO AFRO, through AVAREF, has established a training course for ethics committees in both English and French. AUDA-NEPAD has established Regional Centres of Regulatory Excellence (RCOREs) designated with regulatory science expertise and training capabilities. Moreover, WHO has also developed standards for ranking maturity of regulatory boards as a measure to indicate advancement in capacity of these agencies.

^[2]These initiatives include: the African Medicines Agency (AMA), the Africa Vaccines Regulators Forum (AVAREF), the Regional Centres of Regulatory Excellence (RCORE) in Africa, the WHO-TDR-SIDCER initiative (Strategic Initiative for Developing Capacity in Ethical Review), the Pan African Clinical Trials Registry (PACTR), the African Medicines Regulatory Harmonisation (AMRH) and the Africa Centre for Disease Control and Prevention (ACDC) and WHO-AFRO.

^[3]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/

^[4]The Team Europe initiative (TEI) on Manufacturing and Access to Vaccines, Medicines and Health Technologies (MAV+) https://ec.europa.eu/commission/presscorner/detail/en/ip_21_2594 directly funds the European Medicines Agency (EMA), African Medicine Agency AUDA-NEPAD (AMA) and the World Health Organization (WHO).

^[5]Team Europe Initiative with Africa on sustainable health security using a One Health approach https://europa.eu/capacity4dev/tei-jp-tracker/tei/sustainable%C2%A0health-security-africa