The Department of Trade and Industry (DTI) would like to limit to a maximum of 21-day processing of permits for proponents of vaccine manufacturing projects and to appoint a focal person at the Food and Drugs Administration (FDA) to ensure no red tape for this priority project, which President Duterte wants to leave as his legacy before he steps down from office in June next year.
DTI Secretary Ramon M. Lopez said that concerned government agencies are expected to sign the proposed Greenlane Joint Memorandum Circular by next week. He said the Anti Red Tape Authority (ARTA) has been working with all concerned agencies to finalize the greenlane procedures.
To expedite processing of permits, the DTI suggested that information and documents can be submitted in advance to the FDA, prior to the official assessment.
Lopez said the DTI has emphasized for shorter processing of permits. “The proposed greenlane system is to have 21 days maximum,” said Lopez.
The proposed Greenlane JMC is applicable only to Bulk Importation, Fill and Finish Model under an Emergency Use Authorization Application.
The DTI also emphasized that JMC should provide for a post audit to be adopted by concerned government agencies especially by FDA.
Lopez also asked the designation of a focal unit or person in the FDA for the implementation of the Greenlane processing.
Lopez, however, said that the government has no final commitment yet on the volume of vaccines that it will procure from local vaccine manufacturers once they go into production. He said this is still being deliberated upon by the Department of Health (DOH) and the Vaccine committee.
But he added that local vaccine procurement is possible for now under an EUA certified vaccine using the import -fill-finish model. “This model will allow an earlier start of operations, possibly before yearend or early next year,” he said.
“Also, we’re coordinating with local company as to the timeline they can start actual production,” said Lopez.
Earlier, the Board of Investments, the investment promotion arm of the DTI, has identified at least four vaccine manufacturers and some technology providers interested to establish operations in the country.
Lopez, also BOI chairman, reported that Unilab, the leading pharmaceutical company in Southeast Asia, has been confirmed to do local vaccine manufacturing in the country starting with the COVID-19 with plans to also export to other ASEAN countries, according to Lopez.
As of April 7 this year, Lopez said “Unilab is confirmed to do local vaccine manufacturing starting with COVID-19.”
Unilab is among the four pharmaceutical firms that Lopez presented to Duterte, who expressed his desire to establish a vaccine manufacturing facility in the country as his legacy before he steps down from office in June 2022. The three other pharmaceutical firms are Glovax Biologics, IG/IP Biotech, and Dr. Zen Biotech Inc.
Glovax, a local vaccine distributor in the country, has already signed an agreement with their technology partner Eubiolgics of Korea for local vaccine manufacturing. The company has proposed to locate its P7.5 billion project in Clark. It targets to start operation of a form/fill and finish facility in October 2022.
IG/IP Biotech has also proposed to produce COVID-19 vaccines as well as influenza multivalent vaccines and pneumococal polyvalent vaccines. It seeks a memorandum of understanding with the government’s investment arm National Development Co. and the Board of Investments. It plans to conduct phase 3 clinical trials in the country.
Dr. Zen Biotech Inc. has a proposal for the production of 2nd generation recombinant vaccine for COVID-19, monoclonal antibodies and general injectables with potential technology providers from India and China. It is also looking for possible partnership with Moderna and J & J. It has a project cost of $20 million for phase one and another $20 million for the phase 2.
The company has proposed to set up a form/fill facility in the First Bulacan Industrial Estate complete with class 100 biotech sterile R&D. The design and construction of the plant is ongoing and is expected to start operation by 2022.