Table 6.

Summary of the WHO prequalification process for new vector control tools⁹¹

Phase	Primary outcome	Steps	Factors	Pathway designation
Pre-submission	Define evaluation pathway	Pre-submission to PCC	Pre-submission coordination committee	Pathway designation
New intervention pathway	Validated public health value of product class	Concept review and data definition	VCAG	Defined data required to validate public health value and support a WHO policy recommendation
		Development of assessment standards	VCAG product developer	Developed efficacy test guidelines, SOPs, quality and safety standards, and criteria
		Manufacturer-led data generation	VCAG product developer	Clinical trial results
		PQT inspection	PQT product developer	Report from manufacturing facility inspection
		Data assessment and recommendation to MPAC	VCAG	Final VCAG report to MPAC
Good Manufacturing Practices/Neglected Tropical Disease/PQT Assessment	1) Policy recommendation issued 2) Product prequalified	MPAC/STAG assessment	MPAC	MPAC meeting report
		PQT assessment	PQT	Product listing
Post-recommendation activities	Programmatic use	Country health authority review	MoHs NMCP	Country policy issued
		Country regulatory review	MoHs Reg. authorities	Product registered in country
		Country procurement	MoHs GFTAM/UN/PMI	Product procured by countries
		Country use	MoH NMCP	Roll out and monitoring
Post-PQT activities	Ongoing inspections and assessments	Post-PQT activities	PQT

MPAC = Malaria Policy Advisory Committee; PCC = preferred product characteristics; PQT = prequalification team; VCAG = Vector Control Advisory Group.