Immunization standards

Revised procedure for WHO prequalification of vaccines

A proposed revised procedure for WHO prequalification of vaccines was reviewed and endorsed by WHO's Expert Committee on Biological Standardization (ECBS) in October 2010.

There are a number of reasons for revising the procedure. One of the main reasons is the increasing diversity and complexity of products submitted for prequalification. Another is the increased demand for investigation into potential safety and quality issues, which is diverting staff resources from processing of files submitted for prequalification.

The revised procedure introduces increased collaboration with national regulatory authorities during the initial evaluation and also for post-prequalification activities. The aim is to rely more on information from the evaluations conducted by the NRAs. WHO has established, or is negotiating, collaborating agreements with eligible NRAs, such that they will share information from their own product evaluations and reports of adverse events following immunization and complaints that may impact on the acceptability of vaccines used in countries. This will allow WHO to concentrate it's resources to evaluate issues not covered by the NRA.

The revised procedure also defines, for the first time, specifications for critical and desirable characteristics of vaccines from the perspective of immunization programmes. Evaluating vaccines for these characteristics has always been part of the prequalification procedure, and codifying these characteristics represents a major step forward in terms of making it clear to manufacturers what is required for prequalification. It is expected that, as a result, the time taken for manufacturers to obtain prequalification will be reduced and that products will be better suited to their target populations.

WHO will retain overall responsibility for ensuring that vaccines meet the requirements for global supply through the United Nations, and are suitable for use in those countries procuring through United Nations agencies. WHO will also continue to be responsible for the continuous monitoring of the quality and safety of products.

It is expected that the revised procedure will improve the efficiency of the service without compromising on quality.

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Last update:

8 November 2013 15:04 CET