The World Health Organization has opened its first prequalification pathway specifically targeting a group of priority childhood cancer medicines.
Manufacturers can now submit products for WHO evaluation, with the aim of expanding the pool of quality-assured medicines available for procurement by countries and international programmes.
Which medicines are included
WHO's invitation covers 12 essential cancer medicines for children.
Six were prioritised because suitable paediatric formulations are needed: cyclophosphamide, etoposide, mercaptopurine, methotrexate, procarbazine and temozolomide.
Another six were selected because of documented supply or access gaps: pegaspargase, asparaginase, preservative-free hydrocortisone, dactinomycin, vincristine and cytarabine.
Why formulation matters in children
A medicine can be effective in principle but still be difficult to use safely in children if the formulation is poorly suited to age, body size or local conditions.
Paediatric formulations may need flexible weight-based dosing, suitable dosage forms, acceptable administration, stability in warmer climates, safe handling and packaging that works in resource-limited settings.
WHO says target product profiles were developed for the six medicines where better child-friendly formulations are a priority.
The access gap is large
WHO estimates that about 400,000 children and adolescents develop cancer each year. Nearly 90% live in low- and middle-income countries.
Survival exceeds 80% for many childhood cancers in high-income settings but remains below 30% in many lower-income settings. Drug availability is only one part of that gap, but unreliable supply and lack of quality-assured formulations are important contributors.
What prequalification does
WHO prequalification is a quality-assurance mechanism. It evaluates products against standards for quality, safety and efficacy so that procurement agencies and countries can identify medicines suitable for large-scale purchasing.
It does not itself manufacture or distribute medicines, and it does not guarantee that every country will immediately obtain them. But it can make procurement easier by increasing the number of products with an internationally recognised quality assessment.
WHO says the current initiative is linked to the Global Platform for Access to Childhood Cancer Medicines, which is expected to reach about 120,000 children.
Why this is a systems story, not just a drug story
For childhood cancer, access depends on a chain: diagnosis, pathology, trained clinicians, reliable supply, appropriate formulations, safe administration and follow-up.
The new prequalification route addresses one of those bottlenecks — the availability of quality-assured medicines that health systems can procure with greater confidence.
Its eventual impact will therefore depend on how many manufacturers submit products, how quickly suitable products are evaluated, and whether procurement and treatment systems can translate those approvals into actual patient access.
Primary source
- World Health Organization. WHO advances access to quality-assured, child-friendly cancer medicines. 4 September 2026. https://www.who.int/news/item/04-09-2026-who-advances-access-to-quality-assured--child-friendly-cancer-medicines