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WHO Opens Pathway For Twelve Childhood Cancer Medicines
The World Health Organization wants to make cancer medicines easier and safer for children to use.
It has invited manufacturers to submit products containing 12 important medicines for review.
Six medicines need forms that children can take more easily and receive in accurate doses.
Six others have problems such as shortages or unreliable supply.
The medicines have not been approved by WHO yet.
Manufacturers must provide information, and WHO may inspect factories and test samples.
Products that meet the standards could be added to WHO’s prequalified medicines list.
This list can help countries and eligible buyers find medicines that have been checked for quality.
The effort is meant to help more children receive continuous cancer treatment, especially in poorer countries.
WHO’s first Expression of Interest invites manufacturers to submit 12 childhood cancer medicines for evaluation under its Prequalification Programme.
Six medicines are targeted for more child-friendly formulations, including dispersible tablets, orodispersible minitablets and multiparticulate products.
Six established medicines were selected because of continuing supply, availability or formulation challenges.
The 12 medicines are not automatically prequalified; submitted products must pass WHO reviews of quality, safety, efficacy and manufacturing standards.
The initiative supports the Global Platform for Access to Childhood Cancer Medicines, which aims to eventually reach about 120,000 children.
- Who
- The World Health Organization, manufacturers, governments, healthcare professionals and partner organizations are involved.
- What
- WHO introduced its first Expression of Interest for manufacturers to submit 12 childhood cancer medicines for prequalification evaluation.
- Where
- The pathway is global, with particular relevance for low- and middle-income countries.
- When
- The announcement date is not stated; the medicines were identified following a WHO paediatric drug optimization exercise in January 2024.
- Why
- To improve access to quality-assured, reliably supplied and child-friendly cancer medicines.
Key facts
- Medicines covered
- 12 essential childhood cancer medicines
- Child-friendly formulation group
- Cyclophosphamide, etoposide, mercaptopurine, methotrexate, procarbazine and temozolomide
- Supply and access group
- Pegaspargase, asparaginase, hydrocortisone, dactinomycin, vincristine and cytarabine
- Prequalification status
- No products have been automatically prequalified; manufacturers must submit eligible products for assessment.
- Potential evaluation areas
- Quality, safety, efficacy, manufacturing, quality control, facilities and Good Manufacturing Practices
- Global childhood cancer burden
- About 400,000 children and adolescents develop cancer worldwide each year.
- Platform reach
- The Global Platform for Access to Childhood Cancer Medicines is expected to eventually reach approximately 120,000 children.
Quotes
Alarcos Cieza
Unit Head, Management of NCDs at WHO’s Department of Noncommunicable Diseases and Mental Health
“Another major step towards ensuring that children with cancer can receive the quality-assured medicines they need, wherever they live.”
NDTV





