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Africa must prioritize pharmaceutical self-reliance by boosting local medicine production rooted in global quality standards, said Dr Owen Laws Kaluwa, WHO Representative to Ethiopia, in a keynote address delivered at a regional training workshop on Good Manufacturing Practices (GMP) held in Addis Ababa.
The two-day hands-on workshop, held from 22–23 July 2025, brought together 26 participants from National Regulatory Authorities (NRAs) and pharmaceutical manufacturers across seven East African Community (EAC) member states. It was jointly organized by the Local Production and Assistance Unit in WHO Headquarters, the WHO Regional Office for Africa (AFRO), and the WHO Country Office in Ethiopia, with financial support from The Global Fund to Fight AIDS, Tuberculosis and Malaria.
Designed to strengthen technical capacities in GMP implementation, the training offered a mix of instructional content and case-based learning. Core topics included Quality Management Systems, Quality Risk Management, Corrective and Preventive Actions (CAPA), data integrity, validation practices, and management of critical utility systems such as water and HVAC. The approach strengthened practical skills in complying with current WHO GMP standards and fostered active collaboration between regulatory bodies and industry professionals, enhancing mutual understanding and shared responsibility for quality-assured pharmaceutical production.
Dr Jicui Dong, Unit Head of the WHO Local Production and Assistance Unit, remarked “Compliance with current GMP standards needs both theoretical knowledge and practical skills. It is encouraging to see the commitment of pharmaceutical manufacturers within this region to invest in workforce development and ensure local production of quality pharmaceuticals.”
Opening the workshop, Mr Dejene Daba, Head of the Medicine Manufacturers Inspection and Enforcement Desk at the Ethiopian Food and Drug Authority (EFDA), reaffirmed the agency’s commitment to supporting manufacturers and attaining WHO Maturity Level 3 regulatory status—a benchmark for robust regulatory systems.
Dr Kaluwa underscored that reliance on imported medicines continues to pose significant health security risks for African countries, particularly in times of global supply chain disruptions. “Enhancing local pharmaceutical production is not only a strategic health priority but also an economic and political imperative,” he said.
The workshop represents a concrete step toward building regional capabilities to meet international manufacturing standards, aligning with broader continental goals such as the African Union and Africa CDC.
Distributed by APO Group on behalf of World Health Organization (WHO) – Ethiopia.