Kigali, Rwanda and San Francisco, USA -- Bio Usawa extends congratulations to the Ethiopian Food and Drug Authority (EFDA) on achieving WHO Maturity Level 3 (ML3) recognition this week.

The milestone is a key advancement for Ethiopia’s health system. ML3 validates that EFDA has the capacity and systems to regulate medicines at internationally accepted standards. With that comes stronger patient protections, greater trust in local manufacturing, and faster access to safe, effective, and high-quality medicines.

Ethiopia joins 8 other African nations to have achieved this regulatory milestone, which is essential for laying the regulatory foundation for innovation, access, and sustainability in health.

“Bio Usawa looks forward to working closely with EFDA in advancing our shared mission of ensuring that high-quality and affordable biotherapies are equitably accessible to patients across the continent and beyond,” remarked Mr. Eric Karikari-Boateng, Head of Global Regulatory Strategy at Bio Usawa.

About Bio Usawa Inc.  

Bio Usawa is Rwanda's leading biotechnology company dedicated to democratizing access to life-saving biopharmaceuticals across Africa. Founded on the principle that geographic location should not determine healthcare outcomes, the company specializes in developing and manufacturing affordable, high-quality monoclonal antibodies targeting cancer, diabetes complications, infectious diseases, and autoimmune conditions. Bio Usawa's leadership team brings decades of experience from leading global biotech companies and international regulatory agencies.