By Tobias Lengnan Dapam
The National Agency for Food and Drug Administration and Control (NAFDAC), said it has put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes.
It said the measures include, but are not limited to, diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.
NAFDAC in a statement issued yesterday by Prof Mojisola Christianah Adeyeye, its
Director General, said the antibody test kits (IgG/IgM) can be used in COVID-19 confirmed individuals, who can then be tested at the designated centers 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. The results are only qualitative (positive or negative).
“There has been a global effort by innovative diagnostic companies to develop test kits to aid in detection of the virus in patients to guide the management of the disease. The Agency has recently received many requests for Emergency Use Authorization for some of such diagnostic test kits to support the national response and ensure expanded testing capabilities.”
She said NAFDAC has put in place regulatory measures to ensure quality, safety and efficacy criteria are assessed.
These measures are supported by documentation which include; registration and approval by reference regulatory authorities such as those of Japan, USA, Germany, Canada, European Medicine Agency.
“Also, registration by the Regulatory Authority in the Country of Manufacture, Declaration of Conformity, Validation/performance evaluation /Clinical Evaluation Report”
The statement said NAFDAC is part of the African Medical Devices Forum (AMDF), a Technical Working Group of African Medical Products Regulatory Harmonization (AMRH) that has a joint secretariat with WHO.