The purpose of the guideline is to provide information to stakeholders on the necessary requirements for a complete prequalification dossier for insecticide-treated nets (ITNs). Its aim is to establish the baseline for dossier requirements which are necessary to assess ITN products for the purposes of prequalification, describe the data requirements for fulfilling each dossier module, and to provide standardized information for applicants and testing facilities generating data for ITN prequalification dossiers. The document is supported by implementation guidance documents which provide specific information and considerations for how applicants may approach the generation of supporting information and compilation of a complete product dossier.

WHO Guideline for the prequalification assessment of insecticide-treated nets

Implementation of the WHO Guideline for the prequalification assessment of insecticide-treated nets

The WHO Guideline for the prequalification assessment of ITNs includes requirements for additional studies and more detailed information pertaining to the formulation, manufacturing, and physical chemical characteristics of ITNs.

To ensure that all prequalified products comply with the full requirements of the updated ITN guideline, updated product dossiers are required. It is imperative that the updated information submitted, including any previously submitted and/or reviewed studies are relevant to the current manufacturing process and formulation.  

All products are required to meet the requirements of the updated guideline.

The deadlines and requirements for submission of updated product dossiers are summarized below. Full details can be found here: Implementation Plan. For those products that are already prequalified, the deadlines and requirements differ depending on whether the product was prequalified based on a claim of equivalence. For those products that are currently under assessment or that are nearing submission with a planned submission date prior to 30 June, 2025, the applications will be screened based on the previous requirements, and a timeline for completing any outstanding information that is necessary to meet the new guideline requirements will be required as part of the assessment process or as a post-PQ commitment. For any ITN product submitted after the 30 June, 2025, product dossiers are expected to satisfy the updated guideline requirements. 

Prequalified products and products that are under assessment or nearing submission:

•  Prequalified products
  • Not based on a claim of equivalence – Submit Module 3, 4, 5 requirements for assessment by 31 December 2024
  • Based on a claim of equivalence - Submit a complete product dossier for assessment by 31 December 2025
• Full requirements for each module here: Implementation Plan (slides 4-7)

Products that are under assessment or nearing submission:

• Proposed products currently under assessment or submitted before 30 June 2025:
  •  Applications will be screened based on the previous requirements.
  • Updated forms and templates providing all of the required information that does not require the generation of new data must be submitted as part of the product dossier.
  • During application assessment, any data gaps in the dossier that are linked to the new guidelines will be identified. All data gaps must be filled. The timeline for filling the data gaps depends on the nature of the gap, and may be required as either part of the application assessment or included as Post-PQ commitments. 
• Full details here: Implementation Plan (slide 8)

Proposed products submitted after 30 June 2025:

• Submitted product dossiers are expected to comply with the new guideline 
• Full details here: Implementation Plan (slide 9)

The full implementation plan can be found here: Implementation Plan