On 3 October 2025, Dr Mekdes Daba, Health Minister of Ethiopia, announced a major achievement for the country: the formal recognition of the Ethiopian Food and Drug Authority (EFDA) as a Maturity Level 3 (ML3) regulatory system by the World Health Organization (WHO).
As an ML3 country, Ethiopia now has a stable, well-functioning, and integrated National Regulatory Authority (NRA) for medical products. You can find more information on WHO Maturity Levels for NRAs here.
This achievement strengthens Ethiopia’s health system resilience and supports its agenda for local pharmaceutical production and self-reliance. It also positions Ethiopia to play a leading role in regional regulatory harmonisation and pooled procurement initiatives.
A step forward for Africa!
Before October 2025, only eight countries in Africa had reached ML3 status.
As the ninth African country to do so, the Ethiopian FDA now joins other leading NRAs, including:
- Egyptian Drug Authority (EDA)
- South African Health Products Regulatory Authority (SAHPRA)
- Rwanda Food and Drugs Authority (Rwanda FDA)
- Tanzania Medicines and Medical Devices Authority (TMDA)
- Medicines Control Authority of Zimbabwe (MCAZ)
- National Agency for Food and Drug Administration and Control (NAFDAC)
- Ghana Food and Drug Authority (Ghana FDA)
- Agence Sénégalaise de Réglementation Pharmaceutique (ARP)
What Are the Implications of ML3 Status for Clinical Trials Regulation in Ethiopia?
Clinical Trials Oversight is the eighth regulatory function assessed by the WHO Global Benchmarking Tool (GBT), which awards Maturity Levels to National Regulatory Authorities.
Achieving ML3 status in Ethiopia means:
- Streamlined Clinical Trial Approvals: Sponsors can expect more predictable and transparent review timelines, aligned with international standards.
- Enhanced Oversight: EFDA now has the capacity to monitor trial conduct, ensure compliance with Good Clinical Practice (GCP), and manage adverse event reporting effectively.
- Global Recognition: Ethiopia’s ML3 status enhances its credibility as a host country for multinational clinical trials, potentially attracting greater investment and collaboration.
- Eligibility for WHO-Listed Authority (WLA): ML3 is a prerequisite for becoming a WLA, which would enable EFDA’s regulatory decisions to be recognised globally, further facilitating international trial partnerships.
About Pharmalys
Pharmalys is a global Contract Research Organisation (CRO) established in London, Uk, in 2008, with extensive experience in designing, executing, and reporting clinical trial programmes that meet global regulatory and ethical standards.
Since 2012, our regional headquarters in Dakar, Senegal, has supported the delivery of high-quality clinical research operations across Sub-Saharan Africa. We provide flexible, scalable support to life sciences organisation – from full project management to targeted standalone services – combining global expertise with local insight.
Our work spans therapeutic areas such as metabolic disorders, cardiology, oncology, infectious and respiratory diseases, women’s health, and paediatrics.
At Pharmalys, our mission is to advance health through data excellence and to Count Africa In to the world of clinical research by building sustainable, end-to-end research infrastructure across the continent.
We warmly congratulate Ethiopia and the Ethiopian Food and Drug Authority on achieving WHO Maturity Level 3 recognition, a remarkable accomplishment that strengthens Africa’s leadership in global health research and regulation.
