WHO Guideline for the prequalification assessment of insecticide-treated nets
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
Related to: | Document title: | Current version | Publication Date | Identification of changes |
Parent guideline | November 2023 | 15/12/2023 | ||
1. Module 1 | November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
2. Module 2 | November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 |
| ||
3. Module 3 | November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
3.3.1.1 Example DPF for Single AI incorporated fabric
| November 2023 | 15/12/2023 | ||
3.3.1.2 Example DPF for Dual AI incorporated fabric
| November 2023 | 15/12/2023 | ||
3.3.2 IG – Template DPF for coated ITN fabric
| November 2023 | 15/12/2023 | ||
3.3.2.1 Example DPF for Single AI coated fabric
| November 2023 | 15/12/2023 | ||
April 2024 | 19/04/2024 | Clarification on the declaration of the batch size. | ||
November 2023 | 15/12/2023 | |||
3.5 IG – Declaration of ITN construction and sampling procedure | May 2024 January 2025 | 21/05/2024 29/01/2025 | History of changes - IG – Declaration of ITN construction and sampling procedure | |
3.5.1 IG – Declaration of ITN construction and sampling - Template | November 2023 January 2025 | 15/12/2023 29/01/2025 | Inclusion of request for image to denote wale-wise and course-wise directions in the fabric (slide 2 in the template) | |
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | Link to AMS inserted as related document. | ||
3.8 IG – Flammability | November 2023 | 15/12/2023 | ||
November 2023 May 2024 January 2025 | 19/12/2023 21/05/2024 29/01/2025 | History of changes - IG – Snag strength | ||
November 2023 May 2024 | 19/12/2023 | Link to AMS inserted as related document. | ||
November 2023 May 2024 January 2025 | 19/12/2023 21/05/2024 29/01/2025 | |||
May 2024 | 21/05/2024 | Corrected typos. Added clarification text (i.e., under Fig3 and Fig4). | ||
November 2024 | 12/11/2024 | Corrected cone dimensions | ||
October 2024 | 1/10/2024 | Updated hole cutting pattern and Figure 2 | ||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
3.18 IG - Supporting data considerations for the use of novel bioassays | November 2023 | 15/12/2023 | ||
May 2024 | 21/05/2024 | Corrected typos. Added clarification text (i.e., under Fig3 and Fig4). History of changes - IG – Wash resistance study for ITN fabric | ||
3.20 IG – Determination of wash resistance index test for ITN fabric | February 2024 | 23/2/2024 | Clarification of the test difference with respect to the CIPAC MT195 method. | |
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
December 2023
April 2024 | 19/12/2023
02/04/2024 | Deletion of reference to seam testing for abrasion, hole formation and snag strength tests. Clarification on the presentation and interpretation of the results (section 4) and number of samples (section 3.4). | ||
November 2023 | 15/12/2023 | |||
3.24 IG - Post-storage and in use tolerances in relation to the manufacturing release specifications | Future requirements/ in progress for consultation in 2024 | |||
3.25 Storage stability (future) | Future requirements/ in progress for consultation in 2024 | |||
4. Module 4 | November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
5. Module 5 | November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
November 2024 | 12/11/2024 | Corrected cone dimensions | ||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
November 2023 | 15/12/2023 | |||
5.10 IG – Supporting data considerations for the use of novel bioassays | November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
| November 2023 | 15/12/2023 | ||
| November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
5.13 IG - Community Studies | In progress for consultation in 2024 | |||
6. Module 6 | November 2023 | 15/12/2023 | ||
November 2023 | 15/12/2023 | |||
7. Module 7 | 7.1 Module 7 Data requirements table | In progress for consultation in 2024 | ||
7.2 Module 7 Index | In progress for consultation in 2024 |
The following assessments were conducted to present human health hazard and risk assessments for insecticide-treated nets (ITNs). This includes factory-coated or incorporated ITNs. These assessments may be used by applicants, regulatory authorities and other stakeholders as examples of the implementation of the Generic risk assessment model for insecticide-treated nets, 2nd edition (WHO, 2018).
The product characteristics utilized in the assessments, including the fabric weight (g/m2) and concentration of formulants (g active ingredient/kg net), were selected as representative values which exemplify currently prequalified ITN products.
The assessments are not intended to place a limit on the possible concentration of insecticide or synergist formulants in an ITN, nor are the selected values intended to represent the maximum concentration of formulants at which the assessed risks may become unacceptable.
In support of new product applications or change applications submitted to PQT/VCP, applicants may include reference to these documents as part of the product dossier; however, applicants must determine if the design of their product or certain characteristics would require altering the presented risk assessment to properly reflect and assess the proposed product.
Generic Risk Assessment-Human Health: ITNs formulated with Alpha-cypermethrin
Generic Risk Assessment-Human Health: ITNs formulated with Chlorfenapyr
Generic Risk Assessment-Human Health: ITNs formulated with Deltamethrin
Generic Risk Assessment-Human Health: ITNs formulated with Permethrin
Generic Risk Assessment-Human Health: ITNs formulated with Piperonyl-Butoxide
Generic Risk Assessment-Human Health: ITNs formulated with Pyriproxyfen