By the PharmaTradz BD Team. Published October 2026.
In the space of four months, WHO has opened its prequalification programme to two groups of medicines it had never covered before. In May it invited manufacturers to submit medicines for opioid dependence and overdose. In September it did the same for children's cancer medicines, for the first time ever. In August it also updated its invitation to API manufacturers, which now includes several paediatric oncology substances.
For generic manufacturers this matters more than it might seem. Prequalification is the quality stamp that UN procurement agencies and many donor-funded programmes rely on. Once a product is on the WHO list, it can be bought by UNICEF, the PAHO Strategic Fund and the national programmes that follow their lead. This piece explains what has opened, which products are involved, and how a manufacturer can decide whether to apply.
It is a practical overview for business development and regulatory teams, not regulatory advice. The WHO invitation documents are the reference for any submission.
Why these calls matter
Children with cancer in high-income countries now survive in more than 80% of cases. In low- and middle-income countries, where close to nine in ten of the world's children with cancer live, survival is below 30%. A large part of that gap is simply medicine supply. Many of the drugs involved are decades old and inexpensive, but they are often unavailable, interrupted or of doubtful quality, especially where tenders reward the lowest price above everything else.
The Global Platform for Access to Childhood Cancer Medicines was set up by WHO and St. Jude Children's Research Hospital to change that. St. Jude has committed US$200 million over six years. UNICEF and the PAHO Strategic Fund buy the medicines, and countries receive them free of charge. The first deliveries reached Mongolia and Uzbekistan in February 2025. Shipments have since started to Ecuador, Jordan, Nepal and Zambia, with El Salvador, Ghana, Moldova, Pakistan, Senegal and Sri Lanka in the next group. The initial phases aim to reach around 120,000 children.
The prequalification call is the supply side of the same effort. The platform can only buy what meets the quality bar, and until now there was no WHO route for these products.
The 12 childhood cancer medicines in the call
WHO has split the list in two.
| Group | Medicines | Why they are listed |
|---|---|---|
| Child-friendly formulations | Cyclophosphamide, etoposide, mercaptopurine, methotrexate, procarbazine, temozolomide | Children need doses and forms that adult tablets and capsules do not provide, such as oral liquids or low-strength dispersible forms. |
| Access, supply or formulation gaps | Pegaspargase, asparaginase, hydrocortisone, dactinomycin, vincristine, cytarabine | Frequent shortages, few quality-assured sources, or products that are hard to make, such as the asparaginase enzymes. |
Most of these are established generics. The opportunity is not a new molecule. It is being one of the first quality-assured sources that procurement agencies can buy from.
WHO's 43rd invitation to API manufacturers, dated 18 August 2026, also lists four of these substances under childhood cancer: hydrocortisone sodium succinate, dactinomycin, vincristine and cytarabine. API makers can apply in their own right, which helps finished-product manufacturers that want a pre-assessed source.
The opioid treatment call
The May invitation covers three products: methadone and sublingual buprenorphine for treating opioid dependence, and naloxone for emergency treatment of overdose. WHO estimates that around 61 million people use opioids non-medically, and access to effective treatment remains limited in many countries.
These are controlled medicines, so prequalification is only part of the picture. Import and export authorisations under the international drug control conventions, national quotas and secure distribution still apply. Manufacturers should check those requirements in their target markets before investing in a submission.
What prequalification involves
A WHO assessment looks at three things: the product dossier, the manufacturing sites and, where relevant, the bioequivalence or clinical data. In practice:
- Dossier. A full quality, safety and efficacy file, usually in CTD format. For paediatric products, WHO will look closely at dose flexibility, palatability, excipients that are safe for children, and stability in hot and humid climates.
- Inspection. WHO inspects the finished-product site and, where needed, the API site and any contract research organisation that ran the bioequivalence study. It accepts recent inspections by trusted authorities in some cases.
- Abbreviated routes. Products already approved by a stringent regulatory authority, or by an authority WHO lists as performing at an advanced level, can follow a shorter assessment. This is often the fastest path for companies that already sell in Europe or the US.
- National regulator involvement. WHO asks applicants to inform their national regulator and to allow it to discuss the file with WHO.
There is no fixed deadline in either invitation, but early applicants are more likely to be the first sources listed, and procurement agencies tend to stay with suppliers who perform well.
Is it worth applying? Five questions to ask
- Do we already make the product to a standard WHO will accept? Check your GMP history, dossier quality and stability data for Zone IVb. Gaps here are the usual reason for long assessments.
- Can we make the child-friendly form? For the first six molecules, an adult tablet will not be enough. Formulation development may be the real project, and it may suit a partnership with a specialist developer or CDMO.
- Is the volume realistic? Individual orders may be modest, but they are pooled across many countries and repeat over years. Price matters, but reliability of supply matters more to these buyers.
- Do we have a route for the API? A prequalified or SRA-accepted API source shortens the review. If your current API supplier is not on that path, ask them about the API invitation.
- Who will handle the submission? Prequalification is a regulatory project in its own right. Assign an owner, budget for the inspection, and plan for questions from assessors.
How this links to national tenders
Prequalification also helps beyond UN procurement. Many national programmes, central medical stores and donor-funded tenders accept WHO-prequalified products with a faster or simpler registration. Several of the open tenders on our pharma tender calendar already include oncology medicines from these lists, such as mercaptopurine. For background on checking certificates, see our guide to WHO-GMP certificates.
How PharmaTradz can help
We work with GMP-certified manufacturers, API producers and formulation developers across several regions. If you make one of these medicines and want a development partner, an API source or a route into tenders, or if you are a buyer looking for quality-assured supply, send us your requirement. You can also list a ready dossier on our dossiers for licensing board.
Frequently Asked Questions(FAQs)
Which childhood cancer medicines can be submitted for WHO prequalification?
Twelve: cyclophosphamide, etoposide, mercaptopurine, methotrexate, procarbazine and temozolomide, prioritised for child-friendly formulations, plus pegaspargase, asparaginase, hydrocortisone, dactinomycin, vincristine and cytarabine, chosen because of access, supply or formulation gaps.
Is there a deadline for the WHO childhood cancer prequalification call?
The invitation does not set a closing date. Manufacturers can submit an expression of interest at any time, but early applicants are more likely to be among the first quality-assured sources available to procurement agencies.
Who buys prequalified childhood cancer medicines?
Under the Global Platform for Access to Childhood Cancer Medicines, UNICEF and the PAHO Strategic Fund act as procurement agents and supply the medicines free of charge to participating countries. Prequalification also helps with national tenders that accept WHO-prequalified products.
Can API manufacturers apply separately?
Yes. WHO's API invitation of August 2026 lists hydrocortisone sodium succinate, dactinomycin, vincristine and cytarabine under childhood cancer. Accepted APIs are listed as acceptable in principle for use in finished products.
Is there a faster route for products already approved in Europe or the US?
Products approved by a stringent regulatory authority, or by an authority WHO lists as performing at an advanced level, can usually follow an abbreviated assessment. Check the current WHO procedure for the details.
Which opioid treatment medicines are in the 2026 WHO call?
Methadone and sublingual buprenorphine for opioid dependence, and naloxone for overdose. As controlled medicines they also need the import and export authorisations required under international drug control rules.
