FDA orders quick resolution of pending drug applications

MANILA, Philippines — The Food and Drug Administration (FDA) yesterday ordered the quick resolution of all pending applications filed by various pharmaceutical companies.

FDA director general Eric Domingo said he has instructed concerned officials to resolve the applications lodged by manufacturers since 2014.

The Anti-Red Tape Authority (ARTA) had called out the FDA “for sitting on over 600 drug applications despite completeness of submission of various pharmaceutical companies.”

Domingo noted in a radio interview that the FDA’s Center for Drug Regulation and Research has started tracing these applications.

He claimed that applications involving products that are up for renewal of registration will likely be resolved immediately.

“If they are already old products that have previous registration that are just expiring and have no problems, they should be automatically renewed. That can be done within three days,” he said.

Domingo said when he was appointed acting head of FDA in 2019, there were many applications pending with the agency.

“There were really a lot of backlogs but we were able to reduce them gradually. Still, there are several pending applications,” he said.

Green lane

Yesterday, Trade Secretary Ramon Lopez said the joint memorandum circular (JMC) for the green lane for those planning to set up vaccine manufacturing plants may be signed by next week.

The Department of Trade and Industry (DTI) also said the country has to ramp up production of medical oxygen to prepare for any surge in demand amid the ongoing coronavirus pandemic.?In a Viber message to reporters, Lopez said the ARTA has been working with all concerned agencies to finalize the green lane procedures. Among them are the Department of Health, Department of Science and Technology and FDA.

Lopez said the DTI proposed to have a maximum of 21 days for the processing of permits through the green lane.

“There’s a provision that to expedite processing, advanced information and documents can be submitted to FDA, prior to official assessment,” he said, adding that a post audit and a designated focal unit or person in FDA has been proposed by the DTI.

He said the green lane would apply only to bulk importation, fill and finish model under an emergency use authorization (EUA) application.

Work is also being done to get the government to commit to purchase from local vaccine manufacturers when they start operations.

Lopez said procurement is currently possible under an EUA certified vaccine using the import-fill-finish model. “This model will allow an earlier start of operations, possibly before yearend or early next year,” he added.

Among the firms that have expressed interest in setting up vaccine manufacturing plants in the country are Glovax Biotech Corp., United Laboratories Inc., IG/IP Biotech and Dr. Zen Biotech. – Louella Desiderio