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ARTA, FDA commit to streamline internal systems

Published Feb 22, 2024 09:05 am

The Anti-Red Tape Authority (ARTA) has committed to helping the Food and Drug Administration (FDA) streamline its internal systems and address hiccups that could be detrimental to delivering efficient services to the public.

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ARTA Secretary Ernesto Perez and FDA Director General Dr. Samuel Zacate

In a Kapihan session on Feb. 16 at the ARTA Central Office,  ARTA Secretary Ernesto Perez and FDA Director General Dr. Samuel Zacate discussed potential solutions for issues in terms of application assessments, email responsiveness, and the electronic portal system.

“This [Kapihan] showed ARTA’s proactiveness in not just ensuring compliance of other government agencies with the Ease of Doing Business Law, but also helping [these] government agencies deliver quality services to the transacting public," said Perez.

Zacate said the agency is planning to assign personnel from external service providers to its evaluating bodies, as well as examining its backlogs in registration processing.

Aside from updating the FDA's Citizen Charter, ARTA suggested that they create assessment guidelines and rules to address the slow processing times for new or renewal FDA applications and the lack of uniform evaluations.

To avoid bouncing messages, ARTA also recommended the improvement of FDA's email responsiveness and upgrade their systems to utilize their active email.

As for glitches in the FDA's e-portal system, ARTA advised the agency to partner with external online payment providers and open more over-the-counter payment options.

Perez and Zacate also talked about the repeal of Administrative Order (AO) 67 or the Revised Rules and Regulations on Registration of Pharmaceutical Products,  wherein Perez suggested the potential of harmonizing AO 67 and the revision of fees and charges.

In terms of the non-issuance by FDA of Good Manufacturing Practice (GMP) clearances, inspection schedules, and the Permit to Register (PTR) which have been 50 percent paid in advance, the FDA said they will update ARTA on the complaint they will refer to the appropriate office. 
  
"ARTA and FDA will continue to work closely in order to systemically and strategically address these hiccups in the transactions with the FDA. Both are looking into other interventions to streamline processes in the FDA such as undergoing regulatory process under ARTA’s National Policy on Regulatory Management System (NPRMS)," said ARTA.

 

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