The WHO Prequalification Schemes
Because undertaking prequalification tasks may be beyond the capabilities of national authorities, WHO has, on behalf of all UN agencies, started a prequalification scheme (WHO 2004d) covering AIDS, TB, and artemisinin-containing malaria drugs. The prequalification process is rigorous but efficient. WHO provides a positive list of prequalified products and manufacturers that have applied for and received favorable product assessments and manufacturing site inspections. Since January 2005, the Global Fund to Fight AIDS, Tuberculosis, and Malaria has required recipients to use WHO-prequalified products.
Ensuring quality is also an important aspect of any immunization program. For countries receiving their vaccines through UN agencies, WHO advises on the quality, efficacy, and safety of vaccines on the market through a prequalification of vaccines that entails the following steps: (a) reliance on a fully functional national regulatory authority (NRA) in the country of production and (b) verification of compliance with specifications through a thorough process of independent dossier reviews, testing of samples, site visits, ongoing monitoring of quality, and follow-up of complaints.
For a successful prequalification process, the NRA of the country of production must be functional and empowered by the government. A set of laws and structures must be in place that guarantee the NRA's authority and independence and that the NRA exercises the following functions: licensing, postmarketing surveillance, lot release, laboratory access, GMP inspections, and evaluation of clinical performance. These functions constitute the prerequisite for vaccines of assured quality and are the focus in vaccine regulation.
