Product monitoring

Procurement agencies

A country that does not produce its own vaccines acquires them from providers outside. It is strongly recommended that governments buy their vaccines through a competent procurement body that observes well-established, internationally recognized procurement procedures, whether the vaccines are imported or locally produced. International organizations supporting countries' procurement efforts are:

  • UNICEF Supply division – Copenhagen, Denmark,
  • WHO.

In addition, WHO provides courses in strengthening vaccine procurement skills, which can be accessed at the Global Learning Opportunities for Vaccine Quality website.

Licensing authorities in countries of manufacture

All vaccines used within a national immunization programme must meet WHO prequalification requirements for quality and safety. To assure the quality and safety of vaccines, a country must have a competent and functioning independent National regulatory authority (NRA) that supervises:

  • Licensing the product and product facilities,
  • Surveillance for the vaccine performance in field conditions,
  • Lot release,
  • Laboratory testing,
  • Regular inspection,
  • Compliance with Good Manufacturing Practice (GMP),
  • Evaluation of clinical trial data in licensing decisions. 

Prequalification requirements are rigorous and standardized. Before prequalification is granted, the WHO conducts quality assurance tests on individual vaccine batches, rigorously inspects manufacturing sites and evaluates the National regulatory authority of the country where the vaccine will be produced.

Vaccine manufacturers

Marketing authorisation (MA) holders are expected to provide a summary of relevant new safety information together with a critical evaluation of the risk-benefit balance of the product, in form of periodic benefit-risk evaluation report (PBRER). The evaluation of such reports should ascertain whether further investigations need to be carried out or if changes to the marketing authorisation or product information has to be made.