Prior to the establishment of Rwanda Food and Drugs Authority (Rwanda FDA) in February 2018, there was insufficient infrastructure and human resources to implement and operate an autonomous regulatory institution for both foods and pharmaceuticals. This contributed to inadequate assurance of quality, safety, effectiveness of medicines and food products in Rwanda. With enthusiasm and commitment from the Government of Rwanda and advocacy by WHO and other stakeholders, Rwanda FDA was established. In subsequent years, WHO has continued to help build capacity and strengthen the newly-established institution.

Building operational and regulatory capacities for the sustainability of Rwanda FDA

WHO Rwanda took part in several activities to help build capacity for Rwanda FDA to become more self-sustainable and effective. To begin, the first benchmarking activity that WHO Rwanda helped conduct in 2018 assessed the maturity level of the regulatory institution. At the end of the assessment, 136 recommendations were identified in an Institutional Development Plan (IDP) to move the institution from maturity level 1 to maturity level 3. Following this, WHO Rwanda facilitated the establishment and convening of the Coalition of Interested Parties (CIP), which included WHO (Country Office, Regional Office for Africa, and headquarters), United States Agency for International Development , Global Health Supply Chain Management, Unites States Pharmacopeia/Promoting the Quality of Medicines Plus (UPS/PSM⁺) Management Sciences for Health/Medicines, Technologies, and Pharmaceutical Services Program (MSH/MTaPs), Trademark East Africa, Partners in Health in Rwanda, Food and Agriculture Organization of the United Nations (FAO), University of Rwanda, Ministry of Health, and Rwanda FDA with the aim of supporting the identified gaps the first benchmarking by WHO. WHO Rwanda built strong partnerships through the CIP, which helped achieve consensus among stakeholders on the Rwanda FDA roadmap to implement the recommendations.

To improve operational capacity, WHO Rwanda alongside the other CIP members, supported the development of more than 100 operational regulatory documents including regulations, guidelines, manuals, SOPs, and forms for medicines and food products. Additionally, WHO provided technical assistance necessary for the training of new Rwanda FDA staff. These efforts have resulted in more than 120 qualified staff members newly hired and trained by 2020, helping strengthen human resources capacity and the operations of the institution. Despite being a young organization, Rwanda FDA has been able to license 17 pharmaceutical manufacturing companies (four big and 13 small-scale), more than 700 retail and wholesale pharmacies, and has been able to approve more than 4000 human and veterinary medicines up to February 2021.

All of these efforts have ultimately led Rwanda FDA to better serve the Rwandan population in vital ways throughout the COVID-19 pandemic. The organizational improvements have enabled the appropriate regulation of COVID-19-related products. From the beginning of the pandemic up to now, Rwanda FDA has inspected more than 100 manufacturers and sellers of COVID-19-related products such as hand sanitizers, face masks, face shields, and other personal protective equipment (PPEs). WHO will soon be supporting Rwanda FDA in improving capacity on monitoring and regulation of COVID-19 vaccine quality and safety.

Ongoing evaluations and actions for improvements

To support continued improvements of Rwanda FDA, moreover, WHO is Piloting WHO Global Competency Framework with Rwanda FDA and conducted a needs assessment in coordination with the WHO Regional Office for Africa (AFRO) and WHO headquarters to identify areas of improvement for the regulation of clinical trials. WHO Rwanda has been preparing for the second benchmarking activity scheduled in August 2021. These ongoing evaluation efforts mark a crucial point in time for Rwanda FDA, a time for reflection on the strides of progress made in the sector to identify the organizational changes needed to bring the maturity, efficiency, and effectiveness of Rwanda FDA to the next level. WHO support in Rwanda FDA’s journey, has and will continue to improve regulatory capacity to ensure the quality, safety, and efficacy of health products for the Rwandan population for years to come.

Rwanda FDA in action: The National Food Safety Campaign

The National Food Safety Campaign implemented in August 2020 is an example of how the broader goals and vision of Rwanda FDA are applied on the ground. With uncertainties around transmission pathways amongst the public in the early stages of the pandemic, WHO advocated, in collaboration with the Food and Agriculture Organization of the United Nations, for the National Food Safety Campaign. Though we now know that there is relatively little risk associated with COVID-19 infection from food handling and consumption, it was an opportune moment to inform the public on home-based and market-based food safety. WHO Rwanda worked closely with the Ministry of Health and Rwanda FDA to develop the risk communication and community engagement strategy and material. Messages to familiarize the population on food safety were then disseminated through radio channels, television spots, and posters, targeting the entire population throughout the 30 districts.

As a continuation of these efforts, WHO is supporting Rwanda FDA in developing communication tools in collaboration with the Non-Communicable Disease Division of the Rwanda Biomedical Centre for food labeling. The tool will help improve the understanding and use of processed food labeling in the population as well as inform the processed food manufacturers on appropriate food labeling practices.

Photo caption: Meeting of the Coalition of interested partners to support Rwanda FDA.

Photo credit WHO

Disclaimer: This image was taken during a time of no community transmission of COVID-19. Community transmission is defined as the inability to relate confirmed cases through chains of transmission for a large number of cases, or by increasing positive tests through sentinel samples (routine systematic testing of respiratory samples from established laboratories). Preventative measures such as mask wearing and physical distancing should be used to prevent the spread of COVID-19.