Request to Submit a Vaccine Prequalification Dossier
The manufacturer must communicate its intention to submit a vaccine for PQ evaluation ‒ at any time ‒ by sending an official request to the WHO vaccines Prequalification team. This request should take the form of a letter of intention to be sent to the Coordinator, Quality, Safety and Standards, Department of Essential Medicines and Health Products in WHO, with copies to the vaccines prequalification team lead and the relevant national regulatory authority (NRA), giving details of country and sites of manufacture, licensing status and the presentations put forward to United Nations agencies for procurement.
WHO will acknowledge receipt and acceptance of the application letter by e-mail, with a copy to the NRA. It will respond with an official letter only in those cases where the vaccine will not be accepted because it is not a priority. In such cases, the applicant and the NRA will be advised of the rejection of the application within two weeks of receipt of the official request.
A manufacturer whose request to submit an application for evaluation of a candidate vaccine is accepted will be requested to prepare and submit a Vaccine Prequalification dossier (VPQD) based on the ICH common technical document (CTD).
Note:
- WHO does not assess novel vaccines for which there is insufficient test data on which to base a decision.
- For information on the formatting and requirements of an eCTD dossier please follow this link
Product summary file or CTD
As of 1 January 2021, manufacturers may submit their applications in the common technical document (CTD) format, rather than as a PSF, provided that:
- a detailed cross-referencing of contents is presented
- information required by WHO but not included in the CTD requirements is included.
Where a PSF cross-references to the CTD format, the documentation may be submitted in electronic form only. Electronic documents should be in searchable text where possible.
Pre-submission meeting
As early as possible and before the evaluation process starts, a discussion including representatives of the manufacturer, the responsible NRA (if willing to participate) and WHO should be schedule if considered necessary or desirable by either party. Such meetings are important for discussing programmatic suitability issues and can be scheduled when requested by the manufacturer. Additional meetings may be held during the evaluation process, as required.