WHO undertakes a comprehensive evaluation of the safety, efficacy, and quality of vector control products, based on information submitted by the applicants, and an inspection of the relevant manufacturing site including any contract research organization sites as necessary.

The assessment framework of VCP Prequalification is built on science and policy and includes:

• clear operational policy, guidance, and processes;
• relevant data requirements, testing standards and dossier formats;
• robust pre-market evaluation procedures (safety, quality, and efficacy); and
• post-market activities (change assessments, complaints handling, product reviews, re-assessment of products and/or active ingredients).

The document Overview of the WHO Prequalification Assessment of Vector Control Products was developed to provide manufacturers and other stakeholders with an overview of the WHO prequalification assessment process for VCPs. Manufacturers wishing to apply for WHO prequalification of their product(s) should read this document before applying, so that they can be aware of, and prepared for, all aspects of the prequalification assessment process.
 

The decision to prequalify a product is reliant on two components: Determination of Public Health values, and the Prequalification Process   (See image “WHO Evaluation of VCPs”)

The WHO prequalification process is outlined below (Steps 1 and 2 and the full WHO evaluation process are depicted in the image “New intervention and prequalification pathways”):

1. Applicant submits a Request for Determination of Pathway.
2. Pre-submission Coordination Committee (PCC) reviews application and determines the appropriate pathway for the proposed product.
3. For prequalification - Applicant develops and submits a product dossier which includes data and information to support the safety, efficacy, and quality requirements appropriate to the product type and generated according to good laboratory practices (GLP) and appropriate quality management system.
4. Submission is screened for completeness. Only complete applications are accepted for assessment.
5.  Once an application is determined to be complete, two parallel activities will commence:
   1.  assessment of the application by experts as part of the Assessment Session for Vector Control Products (ASVCP) and Joint Meeting for Pesticide Specifications (JMPS); and
   2.  the inspection of the manufacturing facilities to ensure compliance with WHO-recommended quality standards.
6. Once WHO is satisfied that the prequalification assessment process is complete for the relevant product, and that the product meets WHO prequalification requirements, the product, as manufactured at the declared manufacturing site(s), will be included in the WHO list of prequalified VCPs.

Steps 3-6 and the full WHO evaluation process are depicted in the image “Prequalification Process”