NAFDAC grants companies access to conditional use of test kits on coronavirus patients

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“Thus far, the Agency has processed seventeen applications using the expedited review process but has only granted Emergency approval to seven companies using the criteria listed above.”

Adeyeye said that the antigen tests kits, on the other hand, can detect the COVID-19 antigen in patients with or without symptoms and that the results are only qualitative .

The NAFDAC boss noted that the current COVID-19 pandemic has prompted the agency to put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes. These according to her include diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.

She explained that the full approval of any diagnostic/test kit by NAFDAC for COVID-19 will be subject to in-country validation to assess the sensitivity or rate of failure. According to her, “NAFDAC has reduced the “registration to approval” time from 120 working days to 10 working days due to the COVID-19 pandemic. Thus far, the Agency has processed seventeen applications using the expedited review process but has only granted Emergency approval to seven companies using the criteria listed above.”

 

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