
FDA office in Muntinlupa
Photo courtesy of the Food and Drug Administration
President Ferdinand Marcos Jr. has directed the Food and Drug Administration to streamline the country's drug regulatory processes to improve accessibility and affordability for Filipinos.
In a Palace briefing on Tuesday, FDA Director General Dr. Samuel Zacate said the move aims to lower the prices of generic medicines and accelerate the registration of new common drugs.
"I'd like to confirm that the President has directed the FDA further to streamline the drug application process in the Philippines and to provide further drug accessibility for all Filipinos, and in the future, cheaper medicine for us to be accessible also to Filipino people," Zacate said.
Zacate outlined several key initiatives, including the standardized application process under Administrative Order (AO) No. 67.
According to Zacate, AO No. 67 establishes a "bible" for drug application procedures, providing clarity and consistency for local manufacturers and importers.
"(The Administrative Order) will pave the way for the application per category so that the stakeholders, the local drug manufacturers, and the drug importers will have the proper way to register their products," Zacate said.
He added that the FDA has already formulated policies to lengthen the validation or the validity of the license to operate and the certificate of product registration.
Zacate said the validity was initially extended from the initial three years to a five-year renewal. Now, it will be increased to five five-year initial and ten five-year renewals.
"It will help the stakeholders further their business interest in the drug and strengthen drug accessibility in the country," Zacate said.
He also mentioned that the FDA plans to revise fees to enhance laboratory and testing capabilities, bringing them in line with international standards.
Zacate also revealed the possibility or the establishment of the pharma-zones to give a more drug accessible to those selected three pharma-zones by the Philippine Economic Zone Authority.
“The FDA will have a role so that when the drug enters, there will be a direct testing, direct registration to make it faster with a wider coverage,” Zacate said.