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FDA, SEC applications ordered approved

September 10, 2019

THE Anti-Red Tape Authority (ARTA) on Monday ordered the Food and Drug Administration (FDA) and the Securities and Exchange Commission (SEC) to approve pending applications to ease backlogs.

In an order to FDA Undersecretary and officer-in-charge Rolando Enrique Domingo, ARTA Director General Jeremiah Belgica said the 3,125 renewal applications pending at the food agency should be automatically approved.

Anti-Red Tape Authority (ARTA) Director General Jeremiah Belgica. PHOTO BY RENE H. DILAN

Belgica said that, by virtue of Section 10 of Republic Act 11032, or the “Ease of Doing Business an Efficient Government Service Delivery Act of 2018,” ARTA “declares the completeness of all pending applications [that] have submitted the complete documentary requirements and have paid the required fees until Aug. 8, 2019, or 20 working days immediately prior to the issuance of the order.”

Of these renewal applications, 1,081 are pending at the Center for Food Registration and Research. These are on top of the 27 applications for license renewal also pending there.

Belgica also said pending applications for automatic renewal at the agency’s Center for Drug Regulation and Research (CDRR) stood at 1,818, while applications for the parent certificate of product registration totaled 199.

“Consequently, the foregoing applications are deemed automatically approved and/or…renewed by operation of law, as the case may be,” he added.

“In view thereof, the FDA is hereby ordered to issue the corresponding permits, licenses, or any other certification for the foregoing applications.”

For the SEC, Belgica said four pending applications for the accreditation of auditing firms and external auditors that submitted complete documentary requirements, have been paid and long been pending, were also approved.

“Any refusal would be deemed to be further violation of the law, would expose them [FDA and SEC] to ARTA’s filing of administrative cases against erring public officials,” he added.

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