FDA Director General Samual Zacate plans to reduce the review and approval period for generic drug applications from 120 days to just 45 days.
“I’m on the verge of signing the memorandum circular for the facilitation of FRP for generic drugs; it means it will shorten the 120 days to 45 days,” Zacate said in a press briefing.
Zacate stated this after a sectoral meeting with President Ferdinand R. Marcos Jr. that aimed to streamline the country’s drug regulatory processes.
Zacate explained that the FDA used the Facilitated Review Pathway (FRP) as an alternate registration procedure when making its assessment, referring to the evaluations conducted by a reference drug regulatory agency overseas when making its assessment.
“So, it is a matter of time before I 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. 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,” Zacate said.
Zacate highlighted that these processes had not reduced the number of requirements.
“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,” Zacate said.
