ARTA to ensure green lane for vaccine manufacturers

Published April 19, 2021, 5:00 PM

by Bernie Cahiles-Magkilat

The Anti-Red Tape Authority (ARTA) will meet with concerned agencies to discuss the establishment of  green lane for faster processing of permit applications of local vaccine manufacturers following the directive of President Duterte.

ARTA Director General Jeremiah Belgica said the Department of Health (DOH) and the Food and Drug Administration (FDA) will be invited to attend the conference. The Department of Trade and Industry (DTI) and the Securities and Exchange Commission (SEC) will likewise be requested to attend to thresh out the streamlining of government processes in relation to the issuance of permits for local vaccine manufacturers.

ARTA Director-General Jeremiah Belgica (FACEBOOK/MANILA BULLETIN FILE PHOTO)

DTI Secretary Ramon M. Lopez reported to Duterte that four vaccine manufacturing proponents — United Laboratories (Unilab), Glovax Biologics Corp., IG/IP Biotech, and Dr. Zen Biotech Inc. — have committed to comply with all the required documents but requested that they granted greenlane in the processing of their documents and licenses to facilitate their projects. 

Belgica emphasized that by eliminating red tape, the country can attract local companies to invest in local manufacturing like vaccine production in the country. 

Lopez earlier said that the greenlane will accelerate further the resolution of permit applications of local vaccine manufacturers provided that they have submitted all necessary requirements to concerned agencies.

With this, ARTA czar Belgica, in a separate interview, vowed to keep an eye not only on this matter but also on all other products deemed essential to curb the spread of COVID-19.

Trade and Industry Secretary Ramon Lopez. (ALFRED FRIAS/PRESIDENTIAL PHOTO FILE PHOTO)

Lopez 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 is also scheduled for a meeting with IP/IG Biotech next week, April 20. 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.

 
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