Africa Urged to Boost Local Pharma Production Through WHO GMP Training

Africa must urgently prioritize pharmaceutical self-reliance by scaling up local medicine production rooted in global quality standards, said Dr Owen Laws Kaluwa, WHO Representative to Ethiopia. He delivered the call during a keynote address at a regional training workshop on Good Manufacturing Practices (GMP), held in Addis Ababa from 22–23 July 2025.

The two-day hands-on training brought together 26 participants from National Regulatory Authorities (NRAs) and pharmaceutical manufacturers across seven East African Community (EAC) member states. The workshop was jointly organized by the WHO Local Production and Assistance Unit, the WHO Regional Office for Africa (AFRO), and the WHO Ethiopia Country Office, with financial support from The Global Fund to Fight AIDS, Tuberculosis and Malaria.

Strengthening Technical Capacities

The workshop was structured to strengthen technical expertise in GMP implementation, blending instructional modules with case-based learning. Key training themes included:

• Quality Management Systems (QMS)

• Quality Risk Management (QRM)

• Corrective and Preventive Actions (CAPA)

• Data integrity and validation practices

• Management of critical utility systems (including water systems and HVAC technologies)

This approach ensured participants could apply practical skills in real-world regulatory and manufacturing contexts, improving compliance with WHO’s GMP standards while fostering collaboration between regulators and industry professionals.

WHO and EFDA Leaders Weigh In

Dr Jicui Dong, Head of the WHO Local Production and Assistance Unit, highlighted the dual importance of theory and practice:

“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.”

From the Ethiopian side, Mr Dejene Daba, Head of the Medicine Manufacturers Inspection and Enforcement Desk at the Ethiopian Food and Drug Authority (EFDA), reaffirmed the country’s regulatory ambitions. He noted that Ethiopia is working toward achieving WHO Maturity Level 3—a benchmark status indicating a robust and functional regulatory system capable of effectively overseeing medicine quality and safety.

Reducing Africa’s Dependence on Imports

Dr Kaluwa stressed that Africa’s over-reliance on imported medicines poses both health and economic risks, particularly during global supply chain disruptions such as those seen during the COVID-19 pandemic.

“Enhancing local pharmaceutical production is not only a strategic health priority but also an economic and political imperative,” he said.

By strengthening local capacity and regulatory oversight, African countries can secure greater health sovereignty, reduce dependency on foreign suppliers, and ensure sustainable access to essential medicines.

Advancing Continental Health Goals

The Addis Ababa workshop reflects broader continental aspirations under the African Union (AU) and Africa CDC, which have consistently emphasized the need for regional self-sufficiency in pharmaceutical production. This is in line with Africa’s Agenda 2063 and global health security frameworks, which call for stronger resilience against pandemics and public health emergencies.

By training regulators and manufacturers in line with current WHO GMP standards, the initiative not only improves medicine quality and safety but also boosts Africa’s ability to compete in global pharmaceutical markets.

Looking Forward

Participants agreed that sustained capacity-building, investment in local manufacturing, and strong regulatory frameworks are crucial for Africa’s pharmaceutical transformation journey. With growing political momentum and technical support from WHO and partners, the region is taking concrete steps to reduce dependency and build pharma systems that safeguard both public health and economic stability.