To meet the needs of stakeholders, including member state regulatory authorities and manufacturers, WHO PQT/VCP has developed interim guidance to provide information on the necessary requirements for a complete prequalification dossier specifically for spatial emanators. Its aim is to:
- establish baseline guidance for dossier requirements which are necessary to assess spatial emanator products for the purposes of prequalification,
- describe the data requirements for fulfilling each dossier module, and
- provide information for applicants and testing facilities generating data for spatial emanator prequalification dossiers.
The document is supported by 29 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.
The publication of this guidance, concurrently with the first two prequalification decisions for spatial emanator products, demonstrates PQT/VCP's strong commitment to providing timely support to stakeholders coinciding with the eligibility of new product types for WHO prequalification and to the expansion of the toolbox for vector control products.