Procedure for assessing the acceptability, in principle, of vaccines ...

Once the collaboration agreement is formally established, depending on its nature and
scope, WHO may decide, on a product-by-product basis, to do one or more of the
following:
− review the NRA assessment reports instead of reviewing the PSF;
− review NRA/NCL testing results and their trending, if applicable,
instead of independently testing the final product characteristics;
− review the NRA inspection reports and supplement this with a short
audit focused on aspects related to United Nations tender specifications
instead of conducting a full site audit.
Review of NRA assessment reports instead of the PSF
In this case WHO recognizes the assessment of the marketing authorization/licence
dossier performed by selected NRAs responsible for the regulatory oversight of the
candidate vaccine as the basis for the decision on prequalification. WHO will review
the NRA assessment and inspection reports instead of reviewing the PSF, and may
follow up on queries on the basis of the information provided by the NRA responsible
for the marketing authorization/licensing of the vaccine submitted for prequalification.
If there are questions related to issues not addressed in the NRA reports, WHO will
contact the manufacturer directly and copy the NRA on such exchanges of additional
information.
Typically, the responsible NRA focuses its review neither on aspects that are specific
to the national immunization schedules of countries that receive the vaccines through
the United Nations nor on the programme needs stated in United Nations
specifications. These elements must be assessed by WHO, except in the case of the
EMA scientific opinion procedure (Article 58 of Regulation (EC) No. 726/2004).
In view of the above, a review by WHO of the following aspects would remain
essential:
− mandatory and critical characteristics from the programmatic point of view;
− eligibility, when required, for the AMC through review of the proposed
product characteristics against the target product profile criteria;
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