The pre-submission phase of the Vector Control Product (VCP) prequalification process covers the time from the initial manufacturer contact with WHO to the submission of the full product dossier for evaluation.
Manufacturers interested in the prequalification of a VCP are invited to contact the PQT/VCP prior to the submission of their application(s), to discuss the requirements of the prequalification process and ask any questions.
At any time, the PQT/VCP staff can assist the manufacturer with preparing for the prequalification process through pre-submission meetings and/or teleconferences.
PQ200 – Protocol Review
Prior to submitting an application for a new product or change to a listed product, the applicant may submit protocol(s) for review. The review of protocol process has an estimated time of 3 months, and can be requested by submitting a cover letter (including list of documents provided) and the proposed protocol(s) to firstname.lastname@example.org.
- PQT/VCP does not approve protocol(s), but can provide comments to be considered by the study sponsor/investigator.
- The submission of protocol(s) for which studies have already been initiated or completed is discouraged and this is not a good use of time and resources.
- While PQT/VCP may be requested to review methodologies to be used in clinical trials designed to investigate public health outcomes, these protocol(s) and trials are within the purview of the Vector Control Advisory Group (VCAG).