The World Health Organization (WHO) evaluates the effectiveness of national regulatory authorities in overseeing the quality of medicines and other medical products. Countries are rated from Level 1 to Level 3, depending on their capacity.
Maturity Level 3, awarded by WHO, is given to countries with advanced, modern, and effective systems for controlling the quality of medicines and vaccines.
The Rwanda FDA underwent this evaluation between December 2022 and October 2024. On December 5, 2024, WHO officially announced that Rwanda had achieved Maturity Level 3.
Prof. Bienvenu explained that reaching Maturity Level 3 required substantial effort and capacity building, noting that "the Government of Rwanda has made this possible." He emphasized that this achievement highlights Rwanda's commitment to protecting the public health of its citizens.
"With this recognition, medicines and vaccines produced in Rwanda can now enter the international market. This opens the door for pharmaceutical industries to set up operations in Rwanda, with confidence that their products will be globally accepted," he said.
Currently, a BioNTech factory in Rwanda has started producing vaccines locally, and other companies have expressed plans to establish operations in the country in the near future.
Prof. Bienvenu also pointed out that reaching Maturity Level 3 means that Rwanda's FDA is trusted and recognized for its ability to exchange information and collaborate with other countries and institutions. This includes sharing not only data but also all documents related to medicines and vaccines.
He added, "Rwanda will be able to make decisions regarding the quality of medicines and vaccines that will be used as a benchmark by other countries, just as we will rely on decisions made by other countries."
In total, 18 countries worldwide have achieved Maturity Level 3 for regulating medicines and vaccines, including eight in Africa.
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