The National regulatory authority

Key point

The safety of vaccines is under the mandate of the national vaccine regulatory system including the  National regulatory authority (NRA).

Note: The NIP is also involved, and indeed is a main player, in securing the safety of vaccines and their use. Roles and responsibilities of the NRA, the PVC and the NIP should therefore be clearly defined.

All countries should have a body(s) charged with regulatory oversight to ensure that all medial products, including vaccines, used within the country are safe, effective and of assured quality. The body legally mandated to regulate medical products is commonly known as the regulatory authority (RA) or national regulatory authority (NRA). These terms imply that a single organization is responsible for all regulatory functions. Nevertheless, medical products regulatory oversight may be undertaken by one or more institutions reporting to the same or different senior official. NRAs function within the framework of national medicines policy and overall health policy, and as with any public entity, must abide by principles of transparency, fairness, accountability and other principles of Good Regulatory Practices (GRP).

After marketing authorization (also called registration) and introduction of a vaccine, the NRA’s responsibility to ensure vaccine safety must be met by a strong AEFI surveillance. It is important to ensure exchange of information between the NRA and the system of vaccination delivery or the NIP.

Because the NRA may have limited knowledge of the structure and management of the NIP, it is essential that the immunization programme manager is involved in AEFI surveillance and that everyone’s role in monitoring and responding to vaccine safety issues is clear.

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