WHO assesses EFDA Medicines Laboratory in Ethiopia for Global Quality Listing

ETHIOPIA—A World Health Organization (WHO) team has conducted a technical assistance visit to the Ethiopian Food and Drug Authority (EFDA) Medicines Quality Control Laboratory (MQCL) as part of preparations for the WHO Listing of Quality Control Laboratories (WLQCL).

The three-day mission, held from 22 to 24 September 2026, was led by experts from WHO headquarters’ Regulation and Prequalification Department.

It followed EFDA’s expression of interest in having its medicines laboratory assessed for WHO listing.

Preparing for WHO listing

The visit provided a preliminary assessment of the MQCL’s readiness and identified areas requiring further improvement.

In 2025, EFDA achieved WHO Maturity Level 3 for medicines regulation across all eight applicable regulatory functions, including laboratory testing, under the WHO Global Benchmarking Tool.

However, WHO maturity assessment and laboratory listing are separate processes, making the latest mission an important step in the WLQCL process.

Speaking on behalf of EFDA Director General Ms. Heran Gerba, Deputy Director General Mr. Negash Sime said WHO’s technical support would help the laboratory work towards listing and strengthen its role in Ethiopia and the wider African region.

He also linked the laboratory’s development to Ethiopia’s efforts to expand local pharmaceutical manufacturing.

According to Sime, strengthening domestic production requires a quality control laboratory capable of meeting international standards.

Ms Natércia Guerra Simões, WHO Technical Officer and lead auditor for the mission, presented the objectives and expected outcomes.

She also highlighted the need for the laboratory to maintain continuous improvement as it works towards meeting international quality requirements.

Role of quality control laboratories

Medicines quality control laboratories test pharmaceutical products to determine whether they meet established standards for quality and safety.

When testing identifies products that do not meet these standards, laboratories provide information to regulators, manufacturers and procurers to support appropriate corrective action.

This function is particularly important for medicines used to treat serious diseases and support maternal and child health.

However, laboratories must maintain robust quality systems and technical capacity to produce reliable results.

The WLQCL is a voluntary WHO assessment process for quality control laboratories.

It evaluates laboratories against WHO Good Practices for Pharmaceutical Quality Control Laboratories and, where applicable, WHO Good Practices for Pharmaceutical Microbiology Laboratories and relevant sections of WHO Good Manufacturing Practices.

The WHO includes laboratories that meet the required standards on its list.

Assessment of EFDA laboratory

During the mission, the WHO team assessed EFDA’s MQCL, including its microbiology laboratory.

The experts reviewed testing documentation, conducted laboratory walkthroughs, and held technical discussions with EFDA staff.

The assessment identified strengths and areas for improvement, while the technical sessions gave EFDA experts practical experience relevant to meeting WHO requirements.

WHO said experts at its headquarters, regional, and country levels would continue supporting EFDA as it addresses the assessment findings and works toward WHO listing.

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