FDA to shorten review, approval process of generic drugs from 120 days to 45 days
On the directive of President Ferdinand Marcos Jr., the Food and Drug Administration (FDA) is set to shorten the period of review and approval processes of applications of generic drugs from 120 days down to only 45 days.
“I’m on the verge of signing the memorandum circular for the facilitation of FRP for generic drug ? it means it will shorten the 120 days to 45 days,” FDA Director General Samual Zacate said in a Palace briefing on Tuesday after his sectoral meeting with the President aimed at streamlining the country’s drug regulatory processes.
The FDA uses the Facilitated Review Pathway (FRP) as an alternate registration procedure, where they refer to the evaluations conducted by a reference drug regulatory agency overseas when making its own assessment.
“So, it is a matter of time that I will sign that. So, mas mapapadali iyong proseso, mas mapapabilis at maikli na lang po ang oras because the FDA has two types of regulations, number one is the full review and number two is the recognition and reliance,” Zacate said.
“The generic drug, as long as they have been leveled 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 further explained.
Zacate clarified that the number of requirements has not been reduced for these processes.
“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. Presidential News Desk
