The World Health Organization (WHO) has awarded Rwanda’s Food and Drugs Authority (Rwanda FDA) a Level 3 Maturity Classification (ML3) for its robust and effective quality control systems for medicines and vaccines.
Level 3 is granted to countries with well-established, functional systems for monitoring the quality, safety, and efficacy of medicines and vaccines, reflecting global regulatory standards.
In a press statement, Rwanda FDA highlighted that achieving this milestone underscores the progress Rwanda has made in adhering to international health and safety principles.
These efforts aim to safeguard public health through stringent oversight of medicines and vaccines.
The classification follows a comprehensive evaluation by WHO, which assesses the performance of National Regulatory Authorities (NRAs) for medicines and vaccines.
Rwanda FDA underwent this rigorous assessment in multiple phases, beginning in December 2022 and concluding in October 2024.
Professor Emile Bienvenu, the Director General of Rwanda FDA, expressed pride in this achievement, stating, “We are honored to attain this level. It reaffirms Rwanda’s commitment to fostering sustainable investments and advancements in the healthcare sector. As we celebrate this milestone, we remain dedicated to upholding high standards in medicine and vaccine quality to protect public health.”
Rwanda now joins an elite group of 18 countries worldwide that have attained Level 3 classification, including only eight in Africa.