Medicines briefing, 9 November 2026: Ethiopia’s lab, Africa’s regulator and shortages in South Africa

1. Ethiopia: WHO assesses the national medicines laboratory

From 22 to 24 September 2026, a WHO team made a preliminary assessment of the Medicines Quality Control Laboratory of the Ethiopian Food and Drug Authority (EFDA). It was a step toward WHO listing of quality control laboratories. The laboratory is not yet listed. WHO found strengths and areas to improve, and will keep supporting EFDA as it addresses them. EFDA links the laboratory’s development to Ethiopia’s goal of expanding local pharmaceutical manufacturing.

Why it matters: A laboratory that meets international standards makes it easier to prove that the medicines on the market are of good quality. This fits Ethiopia’s 2026–2030 national strategy against substandard and falsified medical products, launched in December 2025, which includes strengthening regulation and detection and raising public awareness.

2. Africa: the African Medicines Agency opens two hubs in Kigali

On 27 October 2026, during its first AMA Week, the African Medicines Agency inaugurated two hubs at its headquarters in Kigali. One builds the skills of regulators across Africa through training and mentoring. The other works with manufacturers earlier in product development, to help them meet quality, safety and efficacy requirements. Director-General Delese Mimi Darko said Africa should not remain mainly a destination for medical products made elsewhere. Special envoy Michel Sidibé said some molecules wait five or six years for approval across 55 countries, and that sharing assessments could shorten this.

Why it matters: Faster and more coordinated approvals, and stronger local manufacturing, can improve access to quality medicines across the continent, including Ethiopia.

3. South Africa: shortages of essential medicines

Reports on 2 November 2026 describe shortages and rationing of essential medicines in South Africa, including for high blood pressure, cholesterol, diabetes and psychiatric conditions. The national health department blames Middle East tensions and some local manufacturers failing to meet regulatory requirements. Industry voices also point to higher manufacturing costs and global supply disruptions. The opposition party estimates that up to 50 critical medicines are out of stock; this is its own estimate, and the department has not given a figure.

Why it matters: Supply chains are global. Disruptions elsewhere can reach Ethiopian pharmacies and hospitals, so planning stock early and buying from licensed suppliers matter.

Background: WHO data show that at least one in ten medicines in low- and middle-income countries is substandard or falsified.

What DOCFAN is watching: quality control and licensing in Ethiopia, regulatory harmonisation in Africa, and supply risks that could affect our customers’ orders.

Sources

• WHO AFRO: Ethiopia national strategy against substandard and falsified medical products 2026–2030
• Healthcare MEA: WHO assesses EFDA medicines laboratory (25 Sept 2026)
• Healthcare MEA: African Medicines Agency launches two regulatory hubs in Kigali (4 Nov 2026)
• The National: Essential medicines run short as patients face rationing (2 Nov 2026)