Core functions specific to vaccines
Strengthening NRAsThe NRA is usually the main institution mandated to regulate drugs, including vaccines. It has the aim of ensuring the quality, efficacy and safety of the product. NRAs function within the framework of national medicines policy and overall health policy. As with any public body, NRAs must have principles of transparency, fairness and accountability.
NRAs can cover up to six core functions2 specific to vaccines that ensure the quality, efficacy and safety of the vaccines (see table below).
| NRA functions relating to vaccines | |
|---|---|
| FUNCTION 1 Marketing authorization and licensing activities |
Issuing a market authorization, and licensing vaccine production facilities and vaccine distribution facilities. |
| FUNCTION 2 Post-marketing surveillance (including AEFI surveillance) |
Ensuring that post-marketing surveillance is carried out, with a focus on detecting, investigating, and responding to unexpected AEFIs. |
| FUNCTION 3 Vaccine lot release |
Verifying consistency of the safety and quality of different batches of vaccine coming off the production line (lot release). |
| FUNCTION 4 Laboratory access |
Accessing, as needed, a national control laboratory in order to test vaccine samples. |
| FUNCTION 5 Regulatory inspections |
Inspecting vaccine manufacturing sites and distribution channels. |
| FUNCTION 6 Oversight of clinical trials |
Authorizing and monitoring clinical trials to be held in the country. |