THE Food and Drug Administration (FDA) on Sunday, March 15, 2020, clarified that there are no registered Covid-19 diagnostic kits yet available to the public as no company has complied with its minimum set of requirements.
For imported kits, the FDA said it only requires a License to Operate for a distributor and a Certificate of Product Registration from a reliable national regulatory agency, such as FDA counterparts in the US, Japan, Singapore, South Korea and Europe, among others, or a Certificate of Pre-qualification or Emergency Use Listing from the World Health Organization (WHO).
The FDA said there will be no delay in approval because as soon as proper documents are submitted to it, it will immediately issue a certification.
“This is done to safeguard public interest and insure that the available test kits for use are safe and will give useful results,” reads a portion of the FDA statement.
As of now, the only Covid-19 diagnostic test kits used are Polymerase Chain Reaction-based laboratory kits at the Research Institute for Tropical Medicine in Metro Manila that were donated by the WHO.
The field testing of the test kits developed by the University of the Philippines, the National Institutes of Health and the Department of Science and Technology is scheduled on Monday, March 16. (WBS)