Strengthening national regulatory authorities
In an effort to strengthen the capacity of national regulatory systems, (which include institutions such as national regulatory authorities, national control laboratories and immunization programmes) to ensure that only vaccines of assured quality are available for use in immunization programmes, WHO has developed a 5-step process:
1) Establishment of a benchmark based on the detailed description of a functional system;
2) Assessment of the NRA against a published set of indicators (derived from the above benchmark) to evaluate the level of implementation of critical regulatory functions;
3) Elaboration of an institutional development plan (IDP) to address weaknesses and gaps identified;
4) Implementation of the IDP, through the Global Learning Opportunities for Vaccine Quality (formerly the Global Training Network on Vaccine Quality) and other capacity strengthening efforts; and
5) Monitoring of the progress through regular follow-up assessments.
Countries which manufacture vaccines have been the first priority of this assessment and planning process, because of their importance in ensuring adequate supply to meet global vaccine needs. Second-level priority are countries procuring vaccines directly from countries manufacturing without using the services of UN procurement agencies.
Countries receiving vaccines through UN agencies are considered a third-level priority since the WHO vaccine prequalification scheme, provides assurances about the quality and safety of vaccines that can be leveraged by regulatory authorities in these countries.
Last updated 6 February 2012