Covid-19: NAFDAC Grant’s conditional approval for antibodies, antigen test kits
The National Agency for Food and Drug Administration and Control (NAFDAC) has granted conditional approval for emergency use of some medical devices- COVID-19 Antibody and Antigen Test Kits as well as some Personal Protective Equipment (PPEs).
To this end, the agency has granted approval to seven companies for the importation of the products; based on certain regulatory measures and criteria that would ensure quality, safety and efficacy of their usage.
The Director-General of NAFDAC, Prof Mojisola Adeyeye, said in pursuant to the powers conferred on it by section 5 of the NAFDAC Act, to regulate and control the manufacture, importation, exportation distribution sale, use and advertisement of Medical Devices, the agency has taken some regulatory steps in the fight against COVID-19.
She pointed out that 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, according to her include but are not limited to, diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.
She said, “the antibody test kits (IgG/IgM) 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. 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.
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“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 added that NAFDAC has put in place regulatory measures to ensure quality, safety and efficacy criteria are assessed.
She assured that NAFDAC will continue to stay abreast of current best global practices in this area and monitor updates to the WHO collated list of medical devices being used by different countries.
“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 (17) applications using the expedited review process but has only granted Emergency approval to seven (7) companies using the criteria listed above.
“The availability of Personal Protective Equipment (PPE) for health care providers is a critical component of the effort to stem the COVID 19 pandemic. These PPEs include gloves, protective goggles, face shields, protective gowns and masks in the form of particulate respirators and surgical masks.
“These must meet certain technical requirements and specifications in order to achieve the objective and offer some measure of protection to health care providers and limit their exposure to infection”, Adeyeye added.
