WHO prequalification childhood cancer medicines, WHO childhood cancer medicines assessment, WHO prequalified medicines, childhood cancer medicine quality safety efficacy, WHO PQT/MED

Manufacturers interested in having their childhood cancer medicines evaluated through the WHO prequalification programme must submit the required documentation to the WHO Prequalification Unit for assessment. The submission must follow the documentation and information requirements provided by the WHO Prequalification Unit – Medicines Assessment Team (PQT/MED).

WHO’s assessment is designed to determine whether a medicine meets established standards for quality, safety and efficacy. The evaluation can cover not only the medicine itself but also the manufacturing facilities and systems used to produce and test it.

What Does the WHO Assessment Involve?

Depending on the product and applicable requirements, WHO’s evaluation may include:

• Reviewing product data related to quality, safety and efficacy.
• Assessing manufacturing processes and quality-control systems.
• Inspecting manufacturing facilities for compliance with Good Manufacturing Practices (GMP).
• Assessing clinical testing facilities where applicable.
• Randomly sampling medicines for laboratory testing when required.

This assessment process allows WHO to examine whether the product and the relevant manufacturing arrangements meet its recommended standards.

When Can a Medicine Become WHO Prequalified?

Once WHO determines that a medicine and its relevant manufacturing sites meet the required standards, the product can be added to the WHO List of Prequalified Medicines.

Inclusion on the list provides procurement organisations with an additional quality-assurance reference when considering medicines for purchase. However, WHO prequalification does not automatically mean that a medicine will be registered, purchased or supplied in every country. National regulatory and procurement requirements may still apply.

Why WHO Prequalification Matters for Childhood Cancer Medicines

The pathway is intended to increase the number of quality-assured childhood cancer products that can be considered for international and national procurement.

Expanding the pool of medicines that have undergone WHO assessment can provide procurement agencies with more options when sourcing products that meet recognised quality standards. This can support wider efforts to improve access to essential cancer treatment for children, particularly in settings where the availability and quality assurance of medicines remain important challenges.

The broader goal is therefore to help countries and international procurement organisations identify a wider range of quality-assured childhood cancer medicines that may be considered for procurement and use, subject to applicable national requirements.