THE GOVERNMENT will streamline the process for approving drug applications, which will complement plans to establish so-called “pharmaceutical economic zones or pharmazones, the Food and Drug Administration (FDA) said on Tuesday.
Setting up pharmazones in collaboration with the Philippine Economic Zone Authority (PEZA) will attract locators by bringing down production costs, ultimately helping bring down drug prices, FDA Director General Samuel Zacate said at a Palace briefing.
“Pharmazones consolidate companies that are engaged in all aspects of drug manufacturing including research and development, clinical testing and trials as well as regulation,” the Presidential Communications Office said in a statement.
Currently, the government hopes to put up such a zone within Clark Freeport in Central Luzon, Mr. Zacate said.
The two other pharmazones sites have yet to be determined by PEZA, he said.
In 2017, the trading arm of the Department of Trade and Industry (DTI) unveiled a similar plan with the goal of bringing the Philippines up to par with India and other pharmaceutical hubs.
The Philippine International Trading Corp. (PITC) said at the time it had identified 28 initial manufacturing sites for pharmazones.
A technical working group headed by the PITC was created for the project, including PEZA, the Department of Health, the Board of Investments and the Bureau of International Trade Relations as members.
Meanwhile, Mr. Zacate announced plans to shorten the period of review and approval processes for generic drug applications from 120 days to 45.
The streamlining program is known as the Facilitated Review Pathway (FRP) for generic drugs.
FRP is an alternate registration procedure that considers input from overseas regulators who have conducted their own review of the product.
“It is a matter of time” before the memorandum circular authorizing the FRP to proceed, Mr. Zacate said. — Kyle Aristophere T. Atienza