National Control Laboratories
Manufacturers can apply for prequalification of a vaccine only if their national regulatory authority (NRA) (or the NRA of the vaccine-exporting country) is “functional” or a WHO-listed Authority operating at maturity level 3 or above. One of the critiera for such NRAs is that they operate a national control laboratory that can perform lot release testing of prequalified vaccines.
But quality control testing of vaccines is evidently an exacting task and one that is becoming increasingly difficult and costly due to globalization of the vaccine industry, the growing number of vaccine production sites and the increasing complexity of vaccines to be tested. (The list of WHO-contracted laboratories for vaccines testing can be found here.) At the same time, resources available for this vital public health task are limited. To help optimize use of these resources, WHO created the WHO-National Control Laboratory Network for Biologicals (WHO-NNB).
WHO-NNB provides a platform for exchange of quality and technical information on prequalified vaccines to facilitate access to vaccines: through recognition by recipient countries of the lot release of the responsible national regulatory authority (NRA). This cooperation and networking helps ensure efficient testing, saves costs and reduces the risk of inaccurate results. Most importantly, if recipient countries can rely on the lot release performed by the responsible regulatory authority, access to vaccines is be accelerated. The network also promotes development of harmonized common standards and best practice, supports test harmonization and NCL strengthening through technical assistance, the design and application of harmonized test methodologies, the organization of collaborative studies, and confidential sharing of lot release results (based on manufacturers’ consent).
Useful information on this website for NCLs
The sections of this website of most interest and relevance to NCLs are:
- Vaccines Eligible for WHO prequalification — vaccines categorized for prequalification according to four levels of priority: high, medium, low and no priority
- Vaccines under Assessment — summarizes what vaccines are currently under assessment
- WHO List of Prequalified Vaccines — what vaccines have been prequalified and when, in what therapeutic area and formulation; and where manufactured
- Procedures and Fees — presenting all the requirements that must be met for prequalification of a vaccine, the different procedures and fees that are applied
- Post-prequalification Procedures — understand how product performance, quality and safety must be maintained over time
- Prequalification Reports — view Public Assessment and Inspection reports.
- Guidance Documents — browse all current vaccine standards and other general guidance and UN agency operational specifications on preparation, packaging and shipment
- Alternative Evaluation Pathways — information on non-prequalification pathways to regulatory approval
- Complaints Handling — how WHO follows up on complaints received about vaccines, whther these relate to vaccine quality, packaging or presentation defects
- Key Contacts — the key persons who can be contacted regarding different aspects of prequalification, or collaborative registration or technical assistance.