WHO vaccines prequalification relies on national regulatory authorities (NRAs) deemed “functional”, or that have been WHO-listed as operating at (a minimum of) maturity level 3. Manufacturers can apply for prequalification of a vaccine only if their NRA is “functional” or a WHO-listed Authority operating at maturity level 3 or above. Such NRAs have:
- a published set of requirements for licensing
- perform surveillance of vaccine field performance
- operate a system of lot release
- use a national control laboratory
- conduct regular inspections of vaccine manufacturing sites for good management practice
- evaluate clinical performance of vaccines manufactured in their country.
Similarly, NRAs of vaccine-importing countries must have a published set of requirements for licensing and demonstrate capacity to conduct surveillance of vaccine field performance.
In short, WHO vaccines prequalification is reliant on regulatory competence. Conversely, participation in WHO vaccines prequalification offers benefits to NRAs themselves.
The benefits of including WHO-prequalified vaccines in regulatory scope
Engaging in regulatory oversight of WHO-prequalified vaccines offers benefits for NRAs including:
- reputational endorsement implicit in WHO functional status and registration to conduct regulatory oversight of WHO vaccines
- optimized use of resources, for example, through application of the collaborative procedure for registration
- access to WHO prequalification data related to the efficacy of the product in the target population(s)
- incentivizing development of national regulatory capacity.
Prequalification outputs and information of relevance to regulators
Much of the content of this website will be of interest and relevance to regulators dealing with vaccines regulation:
- 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
- Key Contacts — the key persons who can be contacted regarding different aspects of prequalification, or collaborative registration or technical assistance.