December 9, 2024 Kigali, Rwanda and San Francisco, USA

The World Health Organization has just announced that Rwanda and Senegal are the seventh and eighth countries in Africa to achieve ‘Maturity Level 3 (ML3) in its global classification of national regulatory authorities, exemplifying their commitment to ensuring that safe, effective and high-quality medicines are accessible to their populations. 

Bio Usawa (www.biousawa.com), a company devoted to establishing local biomanufacturing capacity in Africa, congratulates this achievement, which will positively impact its goal of developing, manufacturing and distributing affordable biologic therapies to patients in Africa and beyond. The combination of having recently signed a Memorandum of Understanding with the Rwandan Government (BUI-Rwanda MOU), and Rwanda’s new ML3 regulatory status clearly supports reaching these goals. 

Attaining ML3 status reflects the diligent efforts of Rwanda’s FDA and Senegal’s Agence sénégalaise de Réglementation pharmaceutique to ensure access to safe, effective, and high-quality medical products for the protection of public health. The accomplishment is also a significant victory for Africa, a continent striving to transform its Biotechnology and Pharmaceutical sectors by eliminating substandard and falsified medical products. 

"Congratulations to the Rwandan and Senegalese Regulatory Agencies on achieving WHO Maturity Level 3! This remarkable milestone reflects your unwavering commitment to regulatory excellence and the health and safety of your communities,” said Richard Chin, MD, Co-Founder and Board Chair of Bio Usawa. “Your achievements position your countries as leaders in pharmaceutical regulation and inspire confidence for local manufacturing initiatives like ours at Biousawa.”