NAFDAC Grants Conditional Emergency Use Approval of Medical Devices (COVID-19 Antibody and Antigen Test Kits, PPEs, etc.) Companies
April 9, 2020,
The National Agency for Food and Drug Administration and Control, 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, 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, but are not limited to, diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.
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.
NAFDAC has put in place regulatory measures to ensure quality, safety and efficacy criteria are assessed.
These measures are supported by documentation which include the following:
- Prior registration and approval by reference regulatory authorities such as those of Japan, USA, Germany, Canada, European Medicine Agency, etc.
- Registration by the Regulatory Authority in the Country of Manufacture
- Declaration of Conformity
- Validation/performance evaluation /Clinical Evaluation Report
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. Deliberations of the Forum that will be shared with the AMRH Steering Committee for approval and implementation, will further guide NAFDAC. Some of the technical issues that will come out of the deliberations include updates on the list of COVID-19 in vitro diagnostics and medical devices, substandard and falsified commodities and handling of donations.
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.
In addition to these requirements, 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 (i.e., indication of false positives), and specificity.
Failure to comply could lead to revocation of any approval granted for importation of the products and forfeiture of same to the agency for destruction.
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 .
Please note, no vaccines have been approved for any clinical trial. That may not happen before one year to eighteen months, after clinical trials must have been conducted in different countries. This will be followed by rigorous in-country assessment in line with laid down protocols to further ensure safety and efficacy.
NAFDAC………safeguarding the health of the Nation!!!