MANILA, Philippines — The Food and Drug Administration (FDA) is continuously coordinating with Russia’s Gamaleya Research Institute for the requirements needed for the pharma firm’s application for emergency use authorization (EUA) in the Philippines.
The Russian drug company still lacks one requirement which opted the FDA to visit its facility in Russia to verify for itself if Gamaleya is compliant with the standards in manufacturing the COVID-19 vaccine Sputnik.
Gamaleya submitted its application for EUA on January 7 which until today, has not been approved by the FDA.
One document that the firm needs to provide is the certificate of good manufacturing practice, according to FDA Director-General Eric Domingo.
“Sila naman din ang nag-offer na mag-inspect na lang ang Philippine FDA the same with what other countries have done with their manufacturing facility. Iyon na ang naging kasunduan,” Domingo said.
“Ang inspection kasi titingnan mo ang findings, sabihan mo sila kung meron silang kailangang i-correct or kailangang i-explain sa amin kung ano ang measures nila to be sure na iyong findings namin ay ma-address,” he added.
Regulatory inspectors are set to fly to Russia next week.
Once all requirements are complete, the FDA may approve Gamaleya’s EUA for the vaccine Sputnik.
“Ang gusto naman natin matapos na within the month of March kasi ang plano nmin pupunta sila ng March 15 to 18 and the gagawa pa ng report doon it may take a few days after that,” Domingo said.
“Hopefully ang gusto ko matapos na sya within the month of March,” he added.
To date, aside from Gamaleya, another pharmaceutical company with pending EUA application with FDA is India’s Bharat Biotech. – MNP (with reports from Aiko Miguel)