PEZA pharma locators eyed for expedited-permit scheme
PHARMACEUTICAL companies and makers of medical devices who operate in economic zones are being considered for green-lane treatment, entitling them to an expedited process for obtaining permits from drug regulators, the Philippine Economic Zone Authority (PEZA) said.
In a statement, PEZA said the proposal was discussed in a meeting with the Office of the Special Assistant to the President for Investment and Economic Affairs (OSAPIEA) and the Food and Drug Administration (FDA) last week.
“The high-level discussion centered on actionable steps to enhance the ease of doing business for both domestic and export-oriented drug and medical device manufacturers by addressing certain non-tariff barriers, particularly in permitting and licensing,” the investment promotion agency (IPA) said.
PEZA Director General Tereso O. Panga told BusinessWorld that the parties agreed to update the memorandum of agreement (MoA) signed in 2014.
“For this new MoA with the FDA, we agreed to consolidate two MoAs where the cooperating parties will provide a green lane for PEZA-registered business enterprises (involved in) pharmaceutical and medical device manufacturing,” Mr. Panga said in a Viber message.
The new MoA also aims to come up with guidelines for the registration of pharmaceutical industrial parks to provide a one-stop shop for FDA facilitation of permits and clearances and review policies to attract more pharma companies to the Philippines.
Mr. Panga said the goal is to encourage local production to lower the cost of drugs and medical devices, by reducing the turnaround time for pre-assessment activities they are subject to.
On Thursday, PEZA and the FDA unveiled their medical device economic zone initiative.
“We are committed to working in unison with the OSAPIEA and PEZA to simplify business operations in our country,” FDA Director General Samuel A. Zacate said.
“By refining our policies and collaborating with PEZA, we aim to gain a better understanding of the concerns of locators. These initiatives are expected to elevate the local drug supply and reduce costs to competitive generic levels, akin to those in India,” he added.
As of December, PEZA hosted 26 companies manufacturing of pharmaceutical products and medical equipment, accounting for P25.49 billion in investment and 19,000 direct jobs.
“Moreover, PEZA is reviving talks with the leading Filipino companies into pharmaceutical-related activities, such as Lloyd Laboratories, Pascual Laboratories, and United Laboratories, Inc., for the establishment of a modern pharma park,” the IPA said.
“PEZA is also in talks with Royal Cargo Pharma Logistics, the first Good Distribution Practices (GDP)-certified logistics service provider in the Philippines, to complement the proposed pharma-zone ecosystem,” it added. — Justine Irish D. Tabile