Snapshot

The Registration of Imported Drugs in Nigeria pathway has been developed by the National Agency for Food & Drug Administration & Control (NAFDAC) of Nigeria.

This pathway can be used where All products. NB: For New Chemical Entities (NCE), there must be evidence that Clinical Trials have been undertaken in the relevant population. Such clinical trial reports must be submitted and reviewed. No combination drug product shall be registered or considered for registration unless there is scientific documented evidence to prove that such a product has clinical advantage over the single drug available for the same indication(s). Failure to comply with these requirements may result in the disqualification of the application or lead to considerable delay in the processing of registration..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The timeline for product registration from acceptance of submissions to issuance of Registration number is one hundred and twenty (120) working days. Please note that the clock stops once compliances are issued.