ARTA unclogs FDA renewal process


    The Anti-Red Tape Authority (ARTA) has ordered the Food and Drug Administration (FDA) to automatically approve applications that are pending in its office but officials found deliberately delaying the approvals are not yet off the hook

    Jeremiah Belgica, ARTA director-general said he has issued yesterday an order asking Rolando Domingo, officer-in-charge of the FDA to release the licenses of over 3,125 applications for renewal pending with the Center for Food Regulation and Research and the Center for Drug Regulation and Research after finding these applications were ministerial in nature since no changes in the formulation of the products were introduced.

    The move unclogs the centers of 14,000 pending applications that had been the subject of complaints. This would also enable the FDA to act on pending applications for licenses on initial and variant products.

    Belgica said this order does not preclude ARTA from pursuing investigation on officials of the FDA.

    Those found to have deliberately delayed the approvals in exchange of bribes could face administrative and criminal suits.