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

o review and approval of variations/changes;
o extent of the ongoing regulatory oversight exercised for the vaccine of
interest; and
o willingness of the agency to collaborate with WHO in the evaluation
and ongoing regulatory oversight of the vaccine of interest.
Once the performance indicators have been developed and the NRA assessment tool
is revised, thus allowing the establishment of functionality levels, a stepwise
expansion to include additional authorities can be carried out.
4.2 Streamlined procedure for vaccines with marketing
authorization/licensing granted by eligible NRAs
As an alternative to the WHO vaccine prequalification procedure described in section
3, the streamlined option can be applied to vaccines that have been licensed by
selected NRAs which are eligible and willing to share regulatory information with
WHO through a collaboration agreement.
WHO will explicitly request the assistance of the NRA responsible for the regulatory
oversight of the candidate vaccine, and will engage in discussions for the
establishment of a formal collaboration agreement that outlines the shared
understanding of roles, responsibilities and commitments of each party. Provisions for
confidentiality will be also included.
The scope of this agreement can be determined by both parties and could include one
or more of the following (each subject to agreement by the manufacturer):
− sharing of NRA reports relevant to product quality, and nonclinical and
clinical evaluation;
− sharing of NRA/ NCL test results (including the raw data);
− sharing of inspection reports.
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