ITN Product Review Report
During the conversion of WHOPES recommendations to product prequalification listings, insecticide treated nets (ITNs) containing a pyrethroid insecticide in combination with either PBO or a non-pyrethroid insecticide were identified as being supported by partial quality and efficacy assessments, which focussed on the pyrethroid component. While no safety concerns that would preclude conversion to prequalification listings were identified during the conversion action, PQT/VCP indicated, at the time, that a product review process, to identify and address any gaps in the data supporting these products would be initiated. This review is the response to that indication.
A product review process is intended to address an issue which impacts a group of products sharing certain attributes. The process includes:
- Identification of a need for a review of information across multiple products sharing similar characteristics or a class of products
- Identification of the relevant products based on the issue
- Review of existing information
- Identification of new information/data gaps to be addressed
- Applicant submission of information based on the identified needs
- Evaluation of submitted information to inform next steps
WHO has published the Product Review Report concerning ITNs formulated with Pyrethroid+PBO and Pyrethroid+2nd Active in accordance with the key principles of WHO prequalification.
In order to ensure that the confidentiality of information requested, submitted and reviewed through this process is protected, the published Product Review Report is focused on the key findings and recommendations developed by the working group. The key findings, recommendations and complete analysis of the available information will inform the development of new Guidelines and Implementation Guidance for the development of prequalification dossiers for ITNs.