Rwanda
Demographics
Rwanda’s current population is estimated to be around 14.2 million as of November 2023, according to the Worldometer.9 In the past few years, the prevalence of HIV/AIDS has remained stable at 3% for people between the ages of 15 and 48. Furthermore, the TB mortality rate decreased by 81%. Even though there has been progress in several disease burdens, several health challenges remain. The incidence of malaria and non-communicable diseases, as a result of an improved life expectancy, has increased over the last few years. Communicable diseases still account for 90% of the cases at health facilities. At the moment, other health issues, like yellow fever and Rift Valley fever, arise (World Health Organization, 2017). In 2021, the vaccination coverage for the third dose of the DTP-containing vaccine, Hepatitis B, Haemophilus influenzae type B, was 88%. BCG also had a vaccination coverage rate of 89% in 2021 (World Health Organization, 2022c).
Guidelines and Regulations
Laws
Policies
Pharmaceutical Market
The Rwanda Food and Drug Authority is responsible for the regulation of human and veterinary medicines, biological products and vaccines, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco, and tobacco products. In addition to the Rwanda Food and Drug Authority, the headquarters of the African Medicines Agency (AMA) are also based in Rwanda (BCG and Biovac, 2023). Only two of the 35 pharmaceutical manufacturers in Rwanda have received WHO cGMP approval. More than 95% of the medications used locally are imported. They primarily rely on India and China for the importation of raw materials, finished pharmaceutical products, and almost non-existent production of active ingredients. Furthermore, the pharmaceutical market value is estimated to be worth $25 million (Pharmchoices, no date; Mendoza-Ruiz, A., Acosta, A., Escamilla, E. P. V., Torres, 2017).
Vaccination Manufacturing Capacity
Recently, BioNTech announced that they will build the first modular mRNA vaccine manufacturing facility in Rwanda. This was established in collaboration with the KENUP Foundation, the government of Rwanda, the government of Senegal, and the European Commission. The manufacturer will be set up to manufacture products from design to delivery (end-to-end manufacturing) for mRNA-based vaccines, like COVID-19 and BioNTech’s investigational vaccine candidates for malaria and tuberculosis (Pharmaceutical Technology, 2022).