Immunization standards

National Regulatory Authorities

What do we need?

NRAs are national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines) are evaluated properly and meet international standards of quality and safety.
All countries need some sort of NRA, but countries producing vaccines need to exercise six critical control functions, and they need to exercise them in a competent and independent manner, backed up with enforcement power. These six functions are:

  • a published set of requirements for licensing;
  • surveillance of vaccine field performance;
  • system of lot release;
  • use of laboratory when needed;
  • regular inspections for GMP;
  • evaluation of clinical performance.

The documented performance of these functions according to established indicators will be essential to guarantee vaccine quality. These critical control functions depend on vaccine source, as shown below.

Critical control functions depending on vaccine source

Vaccine
source

Licensing Surveillance Lot
Release
Lab Access GMP
Inspections
Clinical Evaluation
UN agency

x

x

. . . .
Procure

x

x

x

x

. .
Produce

x

x

x

x

x

x

 

What is the current situation?

An inventory of performance of national regulatory functions in 55 vaccine producing countries in the world has shown that many of these countries are not fulfilling the necessary role in assurance of vaccine quality. In 1996, only 36 of 55 producing countries (65%) were exercising the necessary six critical control functions. Furthermore, in-depth assessment of some countries according to indicators established by the countries themselves shows that even these functions may not be performed to a depth sufficient to assure vaccine quality.

What must countries do?

As a first step, countries must commit resources, both human and financial to the assurance of vaccine quality. Second, they must critically assess the functioning of their NRAs, and develop a systematic plan that will indicate how identified gaps will be filled, including targets, goals, milestones, and the costs for each step. This plan should include a plan for staff training and accessing needed technical and financial inputs. They must implement these plans and monitor their impact.

What can WHO and other agencies do?

WHO can and is providing technical assistance for the development and implementation of these plans. Support to countries for assessment of their NRA functions is ongoing. Moreover, the Global Training Network on Vaccine Quality (GTN/VQ) is available to provide support in accordance with identified gaps and national plans. Other agencies have indicated their willingness to support these efforts, including, in particular, the World Bank, the Asian Development Bank, and a number of bilateral aid agencies. WHO policy is that no technical nor financial support to vaccine production will be provided to facilities unless they have a functional NRA and have developed a strategic plan to achieve viability.

Vaccine indicators

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.

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