THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much as half, an official said.
“With these three policies, the processes will really be shortened … maybe cut in half,” FDA Director General Samuel A. Zacate told reporters on the sidelines of the launch of the first pharmaceutical economic zone, Victoria Industrial Park.
“We are on track; it is just a matter of time. We just have to follow normal bureaucracy because it is a process,” he added.
Mr. Zacate said that the FDA is set to sign the implementing rules and regulations (IRR) for the registration of drugs and biologicals this month.
“This is a new process. It will be signed this month, we are just fixing it because it has to run through public consultation. The stakeholders and the drug companies must also have a say on the policy, on what the hurdles are, and on what is slowing down the process,” he added.
He said that the new IRR will be presented for public consultation by the third week of May, with signing also due this month.
Meanwhile, he said that a new policy on exporting drugs was approved last year and is currently being implemented.
“We are trying to consolidate everything and streamline the process,” he said.
He said the new policy on exporting drugs will also undergo streamlining by removing the bioavailability and bioequivalence (BABE) study requirement.
“Before, there was duplication — we do BABE here, which takes six months, and then another BABE in the receiving country, which also takes six months,” he said.
“What we did is, as long as the product is only for export, we left it to the receiving country to test it,” he added.
He also cited the Facilitated Registration Pathways, approved last year, which will involve accepting approvals issued by a foreign drug regulator thought to be thorough in its evaluation process.
“The process of approval is reduced because we do not have to evaluate the product; we will just rely on (the foreign regulator’s) evaluation,” he added.
Greenstone Pharmaceutical HK, Inc. Chief Executive Officer Melissa Y. Yap said that the Philippines should move faster in terms of building up its capacity to host pharmaceutical manufacturers.
“We need to move fast because of the trade wars and everything. Other countries are moving so much faster than us,” she said.
Greenstone, which is the manufacturer of Katinko oil and ointment, is the developer of the Victoria Industrial Park.
She said that the company is planning to expand the pharma zone after seeing how fast the first 30 hectares attract locators.
During the launch, the company signed memoranda of understanding and agreement with 14 companies setting up shop at the Victoria Industrial Park.
“There are some big and exciting names that are coming that I cannot name yet; hopefully they (will come) within the next couple of months,” she said.
Besides expanding the pharma zone, she said that Katinko is also looking at expanding its manufacturing capacity.
“We have earmarked around P2 billion,” she said, noting that the expansion will cover its cosmetics and home care products.
“We need to build factories … because our research and development lab create small batches, and we need to move faster,” she added.
Asked if the company is planning to mount an initial public offering, she said there are no plans at the moment, “maybe in five years, but I do not know yet.” — Justine Irish D. Tabile