FOOD and Drug Administration Director General Eric Domingo yesterday ordered the immediate resolution of all pending drug applications filed by various pharmaceutical companies with the agency.
Domingo’s order came a day after the Anti-Red Tape Authority directed FDA Center for Drug Regulation and Research Director Jesusa Cirunayto “explain why no administrative or criminal case should be filed” against her for allegedly sitting on over 600 drug applications filed by various pharmaceutical firms.
The ARTA order was prompted by 23 affidavits from several pharmaceutical companies detailing the alleged delays committed by the FDA-CDRR on their applications, some of which have been lodged since 2014.
“We already ordered the search for these applications that are pending with the FDA,” said Domingo. “Our Center for Drug Regulation and Research has already started tracing these applications. There should be immediate resolution to these applications.”
He said he believes that many of the applications can be immediately approved, especially those up for renewal.
“If they are already old products that have previous registration that are just expiring, and have no problems, they should already be automatically renewed. That can be done within three days,” Domingo said, adding that when he was designated as officer-in-charge of the FDA in 2019, many applications have been pending.
