Information note | 19 December 2024 – The World Health Organization (WHO) evaluates vector control products with the aim of providing assurance to its Member States that interventions meet two sets of criteria.

1. They must have public health value, namely proven efficacy to reduce or prevent infection and/or disease in humans, and;
2. They must meet quality, safety and entomological efficacy standards.

Assessments of the corresponding information for these criteria are conducted under separate procedures overseen by the responsible department.

Assessment of the quality, safety and efficacy of individual health products is part of the remit of the WHO Prequalification programme. This process is managed by the WHO Prequalification Unit - Vector Control Products Assessment Team (PQT-VCP).

Public health value is assessed at the level of an intervention class by means of a first-in-class product generating data that demonstrate epidemiological impact against one or more target diseases. The Vector Control Advisory Group can assist in assuring the quality of the studies and the data are then assessed by the Guidelines Development Group, who develop the evidence-based recommendations for the intervention class. These recommendations – in the case of malaria – are communicated via the consolidated WHO guidelines for malaria. For malaria control interventions, this process is managed by the Global Malaria Programme, and the rest of this note refers to this process.

The first-in-class product must demonstrate a public health impact for the intervention class to be covered by a WHO recommendation. All subsequently developed products submitted for assessment and assigned to this established intervention class and appropriate recommendations under this class are not required to directly demonstrate public health value. Over time, the recommendation will cover a group of interventions that share similar characteristics and entomological modes of action, but will be increasingly diverse due to ongoing innovation.

The Global Malaria Programme previously required a comparative efficacy assessment to ensure that second-in-class products were sufficiently comparable to the first-in-class product to be covered by the appropriate recommendations. This process used a non-inferiority analysis to make the determination.

The data used by this process for insecticide-treated nets (ITNs) and indoor residual spraying (IRS) were largely generated from the experimental hut studies that are conducted as part of the WHO prequalification process. In late 2023, the PQT-VCP incorporated non-inferiority analyses into their assessment of ITNs.

As part of WHO’s efforts to streamline product assessment and recommendation development, the Global Malaria Programme has taken a decision to cease its requirement of comparative efficacy data for second-in-class products. Decisions on inclusion in an existing intervention class will be made as part of the pre-submission coordination committee during the request for determination of pathway. If changes to the WHO guidelines for malaria are required, the Guidelines Development Group will be consulted.

The Global Malaria Programme will continue to evolve its processes to ensure timely assessment and recommendations for new vector control products. If you have any questions, please do not hesitate to contact the Programme’s  Vector Control and Resistance unit at: gmp-vcr@who.int