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Manila Bulletin devider Philippines devider National devider FDA accepting applications for special certification of COVID-19 self-test kits

FDA accepting applications for special certification of COVID-19 self-test kits

Published Jan 6, 2022 11:05 pm

FDA

The country's Food and Drug Administration (FDA) said it is now accepting applications for special certification of self-administered COVID-19 home test kits.

“As of today, we announce that we are accepting applications for Special Certification for COVID-19 self- administered or the home test kit,” said FDA Officer-in-Charge Oscar Gutierrez during the Malacanang briefing aired on Thursday night, Jan. 6.

“I am calling all the manufacturers and even the importers of self-administered COVID-19 test kits to register their product in a form of special certification,” he added.

“We are waiting for the manufacturers and even innovators to register their products and we will know if they will be applying for the nasal or oral (type),” he furthered.

The Department of Health (DOH) is expected to issue the necessary guidelines for the use of the said test kits by Jan. 17.

“We already met with the DOH and they will be coming out with an algorithm or a guideline/policy on the use of home test kits---considering that these products need to be administered by the patient or the household themselves,” said Gutierrez.

“Kailangan natin ng (We need) guidelines on the use, reporting system, even the disposal of the waste, interpretation of the test results, and what actions should the individual take when he finds out that he is positive,” he added.

Epidemiologist Dr. John Wong said it is important to “encourage people to test right away if they are symptomatic” as this will help in cutting the chain of transmission.

“A lot of the transmission is spreading because people are symptomatic,” he said.

On Wednesday, Jan. 5, infectious disease expert Dr. Rontgene Solante said he is in favor of using self-administered test kits.

READ: DOH asking opinion of health experts on use of COVID-19 antigen self-test kits

“I advocated for home testing, especially those with symptoms,” he said during a town hall event organized by Go Negosyo.

“The advantage there, if you are symptomatic and you get the test and you are positive, you can isolate yourself, can do contact tracing early on, and prevent the transmission....compared to going out and having the RT-PCR,” he added.

Remdesivir

In a related development, Gutierrez said that the FDA has also already issued a Certificate of Product Registration (CPR) antiviral drug remdesivir which is being used for the treatment of COVID-19.

“We have already given a CPR last Dec. 27. So that means it can now be supplied to public drug outlets. So dapat mawala na yung black market. This will help prevent overpricing,” said the FDA official.

“We encourage the patients and even their loved ones to buy their medicines from FDA-licensed drug outlets,” he added.

Related Tags

Food and Drug Administration special certification COVID-19 self-test kits home test kits
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