The conditional emergency approval for the production or importation of COVID-19 antibody and antigen test kits, as well as Personal Protective Equipment has been granted to some companies by the National Agency for Food and Drug Administration and Control on Thursday.
A statement by the Director General of the agency, Prof Mojisola Adeyeye, said seven companies had been granted the approval, stressing that NAFDAC had also reduced time for registration and approval from 120 working days to 10 working days due to the COVID-19 pandemic.
The statement said, “NAFDAC, in pursuant to the powers conferred on it by Section 5 of the NAFDAC Act, has taken some regulatory steps in the fight against COVID-19.
“The current COVID-19 pandemic has necessitated that NAFDAC put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes. These include diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.
“The antibody test kits can be used in COVID-19 confirmed individuals, who can then be tested at the designated centres using the antibody kits to confirm that they have antibodies and as such may not be infected again.
“The antigen tests kits on the other hand, can detect the COVID-19 antigen in patients with or without symptoms. There has been a global effort by innovative diagnostic companies to develop test kits to aid in detection of the virus in patients and to guide the management of the disease.
“The agency has recently received many requests for emergency use authorisation for some of such diagnostic test kits to support the national response and ensure expanded testing capabilities.
“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 17 applications using the expedited review process but has only granted emergency approval to seven companies.”
The agency said availability of PPE for health care providers was a critical component of the effort to stem the COVID-19 pandemic, noting that the PPE included gloves, protective goggles, face shields, protective gowns and masks.
NAFDAC warned that so far, no vaccine had been manufactured for coronavirus, adding that it could take up to 18 months before any vaccine could be in place.
