In 1997, WHO launched an initiative to strengthen National Regulatory Authorities in order to ensure that 100% of all vaccines used by national immunization programmes meet standards of quality, safety and efficacy. Three main sources of vaccines were identified (1) countries sourcing their vaccines through UN agencies, (2) countries with direct procurement and (3) producing countries.
An assessment tool using indicators building on existing drug regulatory authorities has been developed to serve as a benchmark and to monitor progress for all countries. This benchmark is also used for prequalifying products that will be purchased by UN agencies. Since 1997, more than 76 countries have provided input to the development of the assessment tool. Revisions were made in 1999, 2001, 2002 and 2004. This revision of vaccine indicators indicates those critical indicators that are essential for NRA capacity and prequalification. The current assessment tool is based on commonalities that were identified in the areas of drugs, vaccines and medical devices. A revision of methodologies used for the assessment of the national regulatory system for vaccines took place in December 2007.
Vaccine indicators (revised December 2007) are available in: