The FDA had yet to start the evaluation of Sinopharm’s application for EUA, according to Domingo.
FDA Director-General Eric Domingo on Wednesday said that the country’s Food and Drug Administration was yet to start its evaluation of China’s Sinopharm’s application for emergency use authorization (EUA) of its COVID-19 vaccine.
In a report on GMA News Online, South Med Pharma was a Philippine-based company that applied for an emergency use authorization for China’s Sinopharm COVID-19 vaccine.
According to Domingo, they had hardly submitted any documents yet as they had just submitted Sinopharm’s Phase 1 clinical trial results and letter of intent.
Domingo also said that they won’t be able to start the evaluation until all the clinical trial data was available.
“Hinihingi pa po namin sa kanila ‘yung mga dokumento na kailangan para ma-evaluate yung kanilang application. Kailangan po natin makita ang katunayan na sila (South Med Pharma) ang local distributor ng Sinopharm sa Pilipinas, iyong resulta ng Phase 3 clinical trials (human trials), certificate ng good manufacturing practices bago maumpisahan ang evaluation [process],” Domingo said.
Domingo also said that South Med Pharma had a license to operate in the Philippines.
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Domingo’s clarification came a day after Presidential spokesperson Harry Roque announced that President Rodrigo Duterte would wait for the Food and Drug Administration to issue an emergency use authorization on China’s Sinopharm before getting the vaccine.
A COVID-19 vaccine needed to secure an emergency use authorization from the Food and Drug Administration for it to be legally administered in the country.
However, the Food and Drug Administration can allow the use of the COVID-19 vaccine without EUA approval provided that the said vaccine secured a “compassionate use permit”.
The issuance of “compassionate use permit” didn’t amount to a stamp of approval from the Food and Drug Administration.
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