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3月2日のまにら新聞から

FDA not yet evaluating EUA application from Sinopharm - Domingo

[ 227 words|2021.3.2|英字 (English) ]

Food and Drug Administration Director General Rolando Enrique Domingo said on Monday that he has yet to check if China's Sinopharm has indeed applied for an emergency use authorization.

He made the statement after Presidential Spokesperson Harry Roque earlier in the day said that Sinopharm has already filed its EUA application with FDA.

"As far as I know, we are not yet evaluating any EUA application from Sinopharm," he said.

He said he has yet to check if his office received the application since their headquarters in Muntinlupa City is closed because its non-working day in the city.

Roque, in a press conference at the Philippine General Hospital Monday morning, announced that Sinopharm has filed its application for EUA.

"They have already filed with the FDA an application for EUA for Sinopharm vaccine," he said.

In the event that Sinopharm applies for EUA, Domingo said the evaluation could take longer than the 21-day target, similar to the process that another Chinese brand Sinovac Biotech had undergone before securing the EUA.

"Perhaps a month, four to six weeks because they (Sinopharm) haven't yet gotten EUA from a stringent regulatory authority or from WHO (World Health Organization). It depends if in the meantime in between their application they can secure like US FDA or UK or Asian countries, which we know have stringent (measures), or WHO," he explained. Celerina Monte/DMS