Regulatory Agencies



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: