Strengthening NRAs

In 1997, WHO launched an initiative to strengthen the capacity of national regulatory systems. These include institutions such as NRAs, national control laboratories and NIPs, and must operate in close collaboration with the vaccine manufacturers. The ultimate objective of this initiative was for all countries to have a reliable, properly functioning NRA. To achieve its objectives, the initiative undertakes a five-step process of capacity development that is customized to the requirements of each individual country.53

  1. Define and regularly update benchmarks and other tools used to assess whether a national regulatory system is capable of ensuring that the vaccines used or made in its country are of the required standards of quality, efficacy and safety.
  2. Use benchmark indicators and other tools to assess the national regulatory system.
  3. Work with the country's regulators and other health officials in drawing up an institutional development plan to deal with any shortcomings in the country's regulatory system, and to build on the existing regulatory strengths in the country.
  4. Implement the institutional development plan, which may involve technical support or staff training to perform regulatory functions.
  5. Re-assess the NRA within 2 years to evaluate progress.

When the initiative started in 1997, only 37 (19%) of WHO's 190 Member States had reliable, fully functioning NRAs. By the end of 2010, the number had risen to 60 (31.5%). Priority countries for the initiative are those that have vaccine manufacturers and thus contribute to the world's vaccine supply. In 1997, 20 (38%) of the 52 vaccine-producing countries had a reliable, functioning NRA. By the end of 2010, the numbers had risen to 34 (77%) of 44 vaccine-producing countries.