World Health Organization (WHO) and Ethiopian Food and Drug Authority (EFDA) strengthen collaboration on medicines and medical devices regulation

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The WHO Representative to Ethiopia, the African Union (AU) and the United Nations Economic Commission for Africa (UNECA), Professor Francis Chisaka Kasolo, held a bilateral meeting with the Director General of the Ethiopian Food and Drug Authority (EFDA), Ms. Heran Gerba, to discuss strengthening Ethiopia’s regulatory systems for medicines and medical devices.

The discussion focused on advancing EFDA’s efforts towards achieving WHO Maturity Level 3 (ML3) for medical devices regulation, reflecting a stable, well-functioning and integrated regulatory system. WHO reaffirmed its commitment to supporting EFDA through the WHO Global Benchmarking Tool Plus Medical Devices (GBT+MD).

Professor Kasolo commended EFDA for building on its achievement of ML3 for medicines regulation and for its continued efforts to strengthen the regulation of medical devices. He also appreciated the successful completion of a WHO-assisted self-benchmarking exercise, which identified EFDA’s strengths and priority areas for improvement against established regulatory criteria.

Ms. Heran highlighted EFDA’s development and implementation of an Institutional Development Plan (IDP) based on the identified areas for improvement. She emphasized the need for coordinated support in key areas, including human resources, infrastructure, digital systems and technical assistance, to advance implementation of the plan.

The meeting also highlighted the importance of advancing vaccine lot release regulation towards ML3 to help ensure access to safe, effective and quality-assured vaccines, while supporting domestic vaccine manufacturing and broader efforts towards vaccine self-reliance.

The meeting reaffirmed the commitment of WHO and EFDA to sustaining and strengthening their collaboration to advance Ethiopia’s regulatory capacity for medicines, medical devices and vaccines, contributing to the availability of safe, effective and quality-assured health products.
Distributed by APO Group on behalf of WHO Regional Office for Africa.

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