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Emergency use authority not needed for home test kit – FDA
FDA director general Eric Domingo explained that the EUA is needed for vaccines and medicines used for COVID-19, but the medical devices, such as the Elluma home testing kits, would only need to apply for a special certificate from the agency.
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Emergency use authority not needed for home test kit – FDA

Sheila Crisostomo (The Philippine Star) - December 19, 2020 - 12:00am

MANILA, Philippines — The emergency use authorization (EUA) recently approved by President Duterte applies only to vaccines and medicines against COVID-19 and is not necessary for test kits, which only need a special certificate, an official of the Food and Drug Administration (FDA) said yesterday.

FDA director general Eric Domingo explained that the EUA is needed for vaccines and medicines used for COVID-19, but the medical devices, such as the Elluma home testing kits, would only need to apply for a special certificate from the agency.

He noted that Elluma has not yet applied for a certification as required under FDA protocols.

Domingo said the EUA will be granted by the FDA if the concerned products have already been given one by a matured regulatory agency abroad.

On the other hand, special certificates are issued to medical devices that are not yet registered but have met various requirements to be used in the country.

At the start of the epidemic, such certification had been issued to testing kits for COVID-19.

The Philippines, according to testing czar Vince Dizon, has already conducted 6.5 million tests for COVID-19, thus allowing the government to intensify early detection of the disease among the population.

At the onset of the Christmas season, he said the government is on the lookout for a possible surge of cases which has been noted in highly urbanized areas like Metro Manila and other big cities.

“So, we need to be always ready… observe the precautionary measures… We are ready to deploy our testing capacity, if needed,” Dizon said in Filipino during the Laging Handa briefing yesterday.

Also a deputy chief implementer of the National Action Plan Against COVID-19, Dizon noted statistics that show government is only about four million tests away from its 10 million tests target for the first quarter of next year.

“The initial target we set is 10 million tests by the first quarter of 2021, and we have reached more than 6.5 million and on the way to reach our target. For 2020, I think we will meet around seven million tests and, by 2021, I am confident that we will surpass our target of 10 million tests by the first quarter,” he said.

While the world has started to get their vaccine supplies, Dizon said the government will continue to aggressively test the population to avoid the spread of the disease.

“The testing, like what our President has repeatedly said, ‘testing and detection, tracing and isolation’ remain important in our fight against COVID-19. The government has addressed testing tremendously since we faced this challenge in the early part of 2020 up to now,” he added.

The government has continuously expanded its testing capacity and accreditation of testing laboratories parallel to the construction and identification of isolation and quarantine facilities.

The increase in the number of tests equipped the government in handling the disease, as well as implementing efforts to prevent the spread of the disease, particularly in densely populated communities.

According to Dizon, the concerned agencies are working on the roll-out of vaccines once acquired by the government and the private sector. He also underscored the role of local government units in the distribution and vaccination for COVID-19, particularly to the most vulnerable population such as frontline medical workers and the elderly.— Christina Mendez

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