WHO conducts preliminary assessment of Ethiopian Food and Drug Authority’s Medicines Quality Control Laboratory toward WHO listing of quality control laboratories

Geneva, Switzerland, 24 September 2026- /African Media Agency (AMA)/ – A team of experts led by the Regulation and Prequalification Department at the World Health Organization (WHO) headquarters conducted a technical assistance visit to the Ethiopian Food and Drug Authority (EFDA) Medicines Quality Control Laboratory (MQCL) from 22 to 24 September 2026. The visit served as a preliminary assessment of the MQCL’s readiness for the WHO Listing of Quality Control Laboratories (WLQCL), following EFDA’s expression of interest in being assessed.

In 2025, EFDA attained WHO Maturity Level 3 for medicines regulation across all eight applicable regulatory functions, including laboratory testing, as assessed using the WHO Global Benchmarking Tool (GBT). WHO listing is a separate process, and this mission marks a foundational step toward WLQCL.

Opening the session on behalf of EFDA Director General Ms Heran Gerba, Deputy Director General Mr Negash Sime said that WHO’s technical assistance would help the MQCL achieve listing, which would benefit both Ethiopia and the wider African region. He noted that local pharmaceutical manufacturing is a national priority for self-reliance and that it depends on a quality control laboratory that meets international standards.

Ms Natércia Guerra Simões, WHO Technical Officer and lead auditor for the mission, outlined the mission’s objectives and expected outcomes, and stressed the need for continuous improvement of the laboratory to meet international quality standards.

Medicines quality control laboratories play a vital role in ensuring that pharmaceutical products meet international standards of quality and safety. When products fail to meet these standards, QCLs alert regulators, procurers and manufacturers so that corrective action can be taken. This role is especially critical for medicines used to treat life-threatening diseases and to promote maternal and child health among vulnerable populations. However, a QCL can fulfil this role only if it operates to international standards itself.

WLQCL is a voluntary procedure through which WHO assesses QCLs against the WHO Good Practices for Pharmaceutical Quality Control Laboratories and, where applicable, the WHO Good Practices for Pharmaceutical Microbiology Laboratories and relevant parts of the WHO Good Manufacturing Practices. Laboratories found to be compliant are included in the WHO List of Quality Control Laboratories.

Listing gives the public greater assurance that medicines are safe and of good quality, allows regulators, manufacturers, and procurers to rely on the laboratory’s results, and strengthens the country’s ability to detect substandard and falsified medicines. Listed QCLs also become eligible to participate in WHO quality monitoring projects for medicines procured by UN agencies.

During the visit, the team assessed EFDA’s MQCL, including its microbiology laboratory, identified strengths and areas for improvement, and made recommendations for achieving full compliance. EFDA experts participated in technical discussions, laboratory walkthroughs and reviews of testing documentation, gaining valuable hands-on capacity-building experience.

WHO, at all three levels of the Organization, reaffirmed its commitment to supporting EFDA in addressing the findings and achieving WHO listing of QCLs.

Distributed by African Media Agency (AMA) on behalf of World Health Organisation.

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Source : African Media Agency (AMA)