Anti-red tape body orders FDA, SEC to recognize backlogged applications

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THE ANTI-RED TAPE Authority reported that pending applications classified as automatic renewal at the FDA are “purely ministerial.” It added that all pending applications on the lists submitted by both agencies are “deemed automatically approved by operation of law.” — WWW.FDA.GOV.PH/

THE Anti-Red Tape Authority (ARTA) has ordered the Food and Drug Administration (FDA) and the Securities and Exchange Commission (SEC) to approve pending applications before them.

The body also ordered both agencies to submit a list of pending applications after surprise visits to their offices last month, ARTA said in a statement yesterday.

SEC submitted a list of four pending applications for accreditation of auditing firms and external auditors.

FDA submitted a list of 3,125 pending applications that included renewal and licensing from the Center for Drug Regulation and Research and the Center for Food Regulation and Research.

In its order, ARTA reported that pending applications classified as automatic renewal at the FDA are “purely ministerial.” It added that all pending applications on the lists submitted by both agencies are “deemed automatically approved by operation of law.”

“All government agencies should effectively comply with the law’s prescribed processing time and remove burdensome processes,” ARTA said in the statement.




Under the law, government agencies have three to 20 days to process permits.

ARTA also said FDA should consult with stakeholders in classifying household and urban hazardous substances, reassign their pharmacists from ministerial tasks, recognize foreign accreditation and delay the payment of fees after the evaluation of applications. — Jenina P. Ibañez

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