(Eagle News)–The Food and Drug Administration is set to shorten the period of review and approval of applications of generic drugs from 120 days to only 45 days.
FDA Director General Samual Zacate made the revelation in a Palace briefing on Tuesday, Feb. 13, after a sectoral meeting with President Bongbong Marcos.
According to Zacate, it was “only a matter of time” before he signs the memorandum circular for the ease of the Facilitated Review Pathway for generic drugs.
The FRP is an alternate registration procedure which sees evaluations conducted by a reference drug regulatory agency overseas are referred to by the FDA when making its own assessment.
He said that while the number of days for the period of review and approval has been reduced, this did not mean the requirements for the same have also been reduced.
“We do not reduce the number of requirements, but we use reliance. Example is that, if it came from, say the US FDA or PMDA, titingnan natin iyong ini-evaluate nila. Iyong mismong papel na ginamit nila, iyon ang titingnan natin. Kapag it has satisfactorily complied with the requirements of the ASEAN common technical documents, hindi na namin uulitin kasi magre-rely kami sa isang stringent regulatory authority,” he said.
“The generic drug, as long as they have been labeled as generic ay wala na silang patent issue at approved naman po sila and it has been in the market of their originating country and then iyong originating country naman niya is strict regulatory agency, pagpasok po noon sa bansa, in-import po natin sa bansa ‘no, it will be subject only to 45 days,” he added.
