The past months have been marked by significant developments within WHO and across the broader global health landscape. In this period of transition, continuity and stability are more important than ever. Our commitment to scientific and technical excellence, impartiality and service to Member States remains steadfast. At the same time, we must adapt to a changing landscape by strengthening collaboration with countries, national and regional regulatory authorities and partners, and by evolving our approaches to meet emerging needs and realities.

The achievements in this issue reflect that combination of continuity and progress. We launched a new Prequalification of Medical Devices programme, expanded the scope of medicines prequalification into new therapeutic areas, and prequalified the first artemether/lumefantrine product manufactured in Africa through complete technology transfer. Mozambique became the 10th African country to reach WHO Maturity Level 3, while our teams continued to strengthen pharmacovigilance systems, market surveillance, and to accelerate access to quality assured health products through the Collaborative Registration Procedure.

By combining continuity with innovation, we will continue to adapt and deliver, ensuring that quality-assured health products remain at the heart of resilient health systems and improved health outcomes worldwide.

Photo: WHO

Assessment of Medical Devices

On 25 September 2026, WHO launched its new Prequalification of Medical Devices programme, a major milestone in expanding access to safe, quality-assured and effective medical devices worldwide. The initial scope includes male and female condoms, intrauterine devices, computer-aided detection software for tuberculosis screening and male circumcision devices. The programme provides an independent, transparent, risk-based assessment framework to support procurement decisions, regulatory convergence and access to quality-assured products, particularly in resource-limited settings.

Photo: WHO/Rolex dela Pena

Assessment of Medical Products

In August, the typhoid conjugate vaccine manufactured by EuBiologics Co., Ltd, Republic of Korea, was added to the list of prequalified vaccines. The multidose vials (5 doses) have a shelf life of 24 months at 2 °C to 8 °C. The team also reviewed and approved 58 variations. Clinical variations included co-administration, age-indication expansion, immunity extension and strain updates for influenza and COVID-19 vaccines. Quality changes included new presentations, shelf-life extension and additional manufacturing sites.

The scope of activities was also expanded to include paediatric cancer medicines and hydroxyurea for sickle cell disease at the request of the relevant WHO departments. The team prequalified the first fixed-dose combination of rifapentine, moxifloxacin and isoniazid for drug-susceptible tuberculosis. It also prequalified the first artemether/lumefantrine product manufactured in Africa through complete technology transfer, supporting local manufacturing capacity.  The team also delivered its ninth annual Medicines Quality Workshop for small-molecule manufacturers and its sixth workshop for biotherapeutic product manufacturers, attracting nearly 250 online participants from all WHO regions.

Photo: Stock photo

Special Prequalification Programmes

The WHO Quality Assurance Mechanism for Modified Mosquito Production (QAM) is open for public consultation until 30 October 2026. This proposed regulatory mechanism addresses the growing need for quality assessments and manufacturing-site audits of modified mosquito products intended for use in public health programmes. Its purpose is to establish an independent WHO assessment of these products and their manufacturing facilities to support Member States and other United Nations bodies. Submit comments to pqvectorcontrol@who.int using the subject line “Comments on Proposed QAM Pilot documents – [Insert organization name].”

Photo: WHO/Hedinn Halldorsson 

Inspection Services

To date in 2026, the Inspection Services team has completed 150 good practice (GxP) inspections (104 onsite and 46 desk assessments leveraging other WHO-listed authorities). It has also published more than 90 WHO Public Inspection Reports and carried out over 35 Quality Management System reviews supporting in vitro diagnostics change requests. Key performance indicators remain on track. The team also supports the WHO Emergency Use Listing procedure by assessing manufacturers' quality systems, conducting 15 desk assessments during the Mpox emergency and nine to date for the Bundibugyo virus disease response.

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Pharmacovigilance

The WHO Pharmacovigilance team contributed to the 2026 WHO–ISoP pharmacovigilance curriculum, published in Drug Safety. As a major update of the 2014 framework, it expands from 15 to 26 chapters with 125 practical learning activities. It addresses priorities such as artificial intelligence, real-world evidence, vaccine safety and signal management. The team is also developing a structured, digitally supported approach to the causality assessment of serious adverse drug events (ADE). It brings adverse drug reactions, medication errors and product-quality problems within a single pathway that identifies not only whether a medicine caused an event, but also the contributing factors and preventive actions. Following expert review in November 2025 and June 2026, the next phase will refine the methodology and pilot it across diverse settings.

Graphic: WHO

Market Surveillance and Control

In July 2026, WHO and Sri Lanka's National Medicines Regulatory Authority held a four-day workshop strengthening the investigation of substandard and falsified medical products, improving skills and interagency coordination among regulators, customs and law enforcement. The team also supported a South-East Asia Regional workshop on biological reference standards; provided technical assistance to the Ethiopian FDA's quality control laboratory ahead of future WHO listing; and supported the WHO Regional Office for Africa in delivering hands-on training in Gaborone, Botswana for participants from 10 African countries and two South-East Asian countries on determining ethylene glycol and diethylene glycol in oral liquid solutions.

Photos: WHO

Regulatory Systems Strengthening

In August 2026, Mozambique achieved WHO Maturity Level 3 (ML3) for the regulation of medicines and imported vaccines, becoming the 10th African country and the first Portuguese-speaking country in Africa to reach this milestone. The recognition confirms that ANARME operates a stable, well-functioning regulatory system, strengthening assurance of the quality, safety and efficacy of health products. Mozambique's achievement of ML3 and South Africa's retention of ML 3 for vaccine regulation, were both recommended by WHO's Technical Advisory Group on Regulatory Systems Strengthening.

Photo: WHO

Special Access Programme

The WHO Special Access Programme has increased transparency on Collaborative Registration Procedure (CRP) review timelines on the WHO website. For registrations from the first quarter of 2026 onwards, the list of approved CRP products now indicates the review time used by each national regulatory authority (≤ or > 90 working days). The two CRP guidelines are also being updated following public consultation. In addition, the WHO CRP Annual Meeting is scheduled for 24–26 November 2026 and will be held in a hybrid format, with limited in-person participation at WHO headquarters in Geneva.

Photo: WHO