FDA to slash generic drug review to 45 days
MANILA, Philippines — The country's Food and Drug Administration (FDA) announced Tuesday that it will shorten the review and approval process for generic drug applications to only 45 days from 120 days.
This move, aligned with President Ferdinand Marcos Jr.'s directive to streamline procedures, aims to make essential medicines more accessible to the public.
"The process will be simplified. It will be faster and shorter," FDA Director General Samuel Zacate said.
"A generic drug, as long as they have been labeled as generic, wala na silang patent issue, approved na sila, and it has been in the market of their originating country and then iyong originating country has a strict regulatory agency, pagpasok sa bansa, it will be subject to only 45 days," he added.
(A generic drug, as long as it has been labeled as generic, no longer has patent issues, is already approved, has been in the market of their originating country that has a strict regulatory agency, when we import it into the country, it will only be subject to 45 days.)
Jesusa Joyce Cirunay, director of FDA's Central Drug Regulation and Research, clarified that the agency would not reduce the number of requirements, but rely on the evaluations of stringent regulatory bodies like the US FDA.
FDA would also lengthen the validity of licenses to operate and certificate of product registration to five to 10 years, an increase from three to five years.