Period of review sa generic drugs pinaigsi ni Pangulong Marcos Jr.
Inatasan ni Pangulong Marcos Jr., ang Food and Drug Administration (FDA) na paigsin sa 45 araw mula sa 125 araw ang “period of review and approval processes” sa mga aplikasyon ng generic drugs.
“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,” pagbabahagi ni FDA Dir. Gen. Samual Zacate matapos ang kanyang pakikipagpulong kay Pangulong Marcos Jr.
Dagdag pa ni Zacate nais ng Punong Ehekutibo na mapadali at mapabilis ang proseso para sa mga gamot.
“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,” banggit pa ng opisyal sa briefing sa Malakanyang.
Dagdag pa niya: “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.”
Nilinaw na lamang din ni Zacate na hindi nagbago ang requirements para sa aplikasyon.
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