DOH can apply for EUA as a public health user, according to FDA Philippines
The Philippine government — through the Department of Health (DOH) — can apply for an emergency use authorization (EUA) for COVID-19 vaccines and drugs with the Food and Drug Administration (FDA).
This, as FDA Director General Eric Domingo said in an interview on Double B sa News TV that there were no COVID-19 vaccine makers that had applied for an emergency use authorization so far.
Early this month, President Rodrigo Duterte issued an executive order allowing the Food and Drug Administration to issue emergency use authorization for COVID-19 vaccines and drugs.
An emergency use authorization would decrease the processing time for the approval of the vaccines for local use from 6 months to 21 days, officials said earlier.
READ ALSO: President Duterte Allows FDA to Grant Emergency Use of COVID-19 Vaccines
In a report on GMA News Online last Saturday, Domingo said that manufacturers can apply for an emergency use authorization or the Department of Health, on behalf of the Philippine government.
However, Domingo said this didn’t guarantee that Department of Health’s emergency use authorization can be approved automatically since the Food and Drug Administration still needed pertinent documents and data.
Also, Domingo said that the Department of Health should secure such documents and data for the Food and Drug Administration’s evaluation.
“Ibig sabihin meron silang kasunduan na ibibigay ang datos. Kasi ‘yung mga papeles, lahat ng dokumento to show certificate of good manufacturing practice, testing… manggagaling sa manufacturer. Hindi makukuha ‘yun ng bibili kung hindi sila magkakasunduan ng manufacturer,” Domingo said.
Moreover, Domingo said that there’s no guarantee that manufacturers were ready to supply vaccines to the Philippines even if the Food and Drug Administration granted emergency use authorization for a vaccine.
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