FDA told: Streamline drug regulatory process

President Ferdinand Marcos Jr. has directed the Food and Drug Administration to streamline the 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 to further streamline the drug application process and to provide further drug accessibility for all Filipinos, and in the future make cheaper medicine accessible to the people,” Zacate said.

He outlined several key initiatives, including the standardized application process under Administrative Order No. 67.

According to Zacate, AO 67 establishes a “bible” for drug application procedures, providing clarity and consistency for local manufacturers and importers.

“(The AO) will pave the way for the application per category so that the stakeholders, the local drug manufacturers, and the drug importers will have a proper way to register their products,” Zacate said.

He said the FDA has formulated policies to lengthen the validation or validity of licenses to operate and certificates of product registration.

Zacate said the validity was first extended from the initial three years to a five-year renewal. Now it will be increased to 10-year renewals.

“This will help the stakeholders further their business interests and strengthen drug accessibility in the country,” Zacate said.

He said the FDA also plans to revise the fees to enhance laboratory and testing capabilities, bringing them in line with international standards.

Zarate revealed the possibility of establishing pharma zones by the Philippine Economic Zone Authority to make drugs more accessible.

“The FDA will have a role in that so that when the drug enters, there will be direct testing, direct registration to make it faster with a wider coverage,” he said.