Snapshot

The Licensing or Access to COVID-19 Vaccines pathway has been developed by the National Agency for Food & Drug Administration & Control (NAFDAC) of Nigeria.

This pathway can be used where COVID-19 vaccines for use in public health emergencies..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

NAFDAC will accept a Rolling Submission and conduct a Rolling Review as it understands that in the pandemic emergency, it is possible that not all documentation for a vaccine will be available at the time of application, and the Agency shall accept that applicants will submit the evidence as it becomes available. It would be expected that the sections on manufacturing, specifications and controls would be available, together with evidence of consistency of manufacture. For nonclinical safety studies, preliminary results should be available. An abridged clinical study to generate data for target population may be required. The results of stability studies would be delayed as would any results from clinical studies. However, this may not be applicable to vaccines manufactured using novel construct or formulation. Where possible Participation in a joint review at the regional or global level is acceptable.