Anti-Red Tape Authority (ARTA) Director-General Sec. Jeremiah Belgica lauded the Food and Drug Administration (FDA) for resolving red tape issues involving COVID-19 saliva testing kits a day after their meeting.
On Wednesday (July 28), the FDA certified that the 2019-nCov nucleic acid-based diagnostic reagent kit (fluorescent PCR) manufactured by Sansure Biotech Inc. has complied with all the requirements for the special certification of COVID-19 diagnostic kits.
The said kits have a medical device registration certification from the National Medical Products Administration (NMPA) in China and are already being used by the Philippine Red Cross (PRC).
The certificate was issued after ARTA met with FDA Center for Device Regulation, Radiation Health, and Research Director IV Maria Cecilia C. Matienzo, who signed the certificate, and representatives from the Research Institute for Tropical Medicine (RITM) and private stakeholders, on Tuesday (July 27).
“We commend the FDA for immediately making moves to cut red tape within their agency. Thank you for keeping an open mind during our meeting, being truthful, and imbibing the spirit of bayanihan and making things work amid the COVID-19 pandemic,” Belgica said.
“With the issuance of the FDA certification for the saliva testing kits, we hope to encourage more Filipinos to get tested for COVID-19, especially now that we are preparing for the possible surge of COVID cases due to the Delta variant,” the ARTA chief added.
During the meeting, representatives from private establishments, such as the Chinese General Hospital (CGH), Philippine Airport Diagnostic Laboratory (PADLAB), New World Diagnostics Inc., and St. Luke’s Medical Center aired their frustration over the delay in the issuance of the FDA certificate for the COVID-19 saliva testing kits.
The said private establishments have already received certifications from the RITM to use the saliva testing kits.
The CGH claimed that they were being asked by the FDA for additional documents before they could receive a certificate to use the said testing kits.
Dr. Samuel Ang of CGH and Mickey Gonzaga, PADLAB chief operating officer, argued that the saliva testing kit is cheaper than the nasal swab test or the polymerase chain reaction (PCR) test dubbed as the “gold standard” by the Department of Health (DOH).
The private stakeholders also pointed out that the saliva testing kits are less invasive and painful than the nasal swab test.
The ARTA chief urged government agencies to hasten and remove any unnecessary processes within their agencies, especially amid the pandemic.
“The science itself has already been established so, what’s keeping this is the bureucratic processes,” he said. “We’ll leave the sciences to you, pero kung processes lang naman, pagtulungan natin so we can finish this in record time.”
ARTA and the said agencies and stakeholders are set to meet again to address other issues which can be resolved through streamlining of processes. (ARTA) – jlo
